Cala ONE Device for Essential Tremor

• ClinicalTrials.gov Identifier: NCT02629614
• Recruitment Status: Completed
• First Posted: December 14, 2015
• Results First Posted: July 18, 2023
• Last Update Posted: July 18, 2023
• Sponsor: Cala Health, Inc.
• Information provided by (Responsible Party): Cala Health, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Essential Tremor
• Intervention: Device: Cala ONE Device
• Enrollment: 93

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Period Title: Overall Study
Started	48	45
Completed	48	44
Not Completed	0	1

Baseline Characteristics

Arm/Group Title		TAPS Stimulation	Sham Stimulation	Total
Arm/Group Description		Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	Total of all reporting groups
Overall Number of Baseline Participants		48	45	93
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	45 participants	93 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	12 25.0%	12 26.7%	24 25.8%
	>=65 years	36 75.0%	33 73.3%	69 74.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	48 participants	45 participants	93 participants
		70.5 (11.2)	69.8 (10.1)	70.2 (10.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	45 participants	93 participants
	Female	25 52.1%	23 51.1%	48 51.6%
	Male	23 47.9%	22 48.9%	45 48.4%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	45 participants	93 participants
	Hispanic or Latino	2 4.2%	0 0.0%	2 2.2%
	Not Hispanic or Latino	45 93.8%	45 100.0%	90 96.8%
	Unknown or Not Reported	1 2.1%	0 0.0%	1 1.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	48 participants	45 participants	93 participants
	American Indian or Alaska Native	0 0.0%	1 2.2%	1 1.1%
	Asian	0 0.0%	1 2.2%	1 1.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	47 97.9%	41 91.1%	88 94.6%
	More than one race	1 2.1%	2 4.4%	3 3.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Change in TETRAS Spiral Rating After Stimulation
Description	The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.95 (0.68)	2.63 (0.52)
Post Stimulation	2.41 (1)	2.23 (0.80)

2. Secondary Outcome

Title	Change in TETRAS Spiral Rating During Stimulation
Description	An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and 30 minutes into stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.95 (0.68)	2.63 (0.52)
During Stimulation	2.58 (0.90)	2.26 (0.67)

3. Secondary Outcome

Title	Self-report Improvement
Description	The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse).
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Measure Type: Count of Participants; Unit of Measure: Participants
	35 87.5%	23 62.2%

4. Other Pre-specified Outcome

Title	Change in Kinetic Tremor
Description	The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.29 (0.47)	2.27 (0.47)
Change after stimulation	-0.53 (0.59)	-0.34 (0.43)

5. Other Pre-specified Outcome

Title	Change in Kinetic Tremor
Description	The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and 30 minutes into stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.29 (0.47)	2.27 (0.47)
Change during stimulation	-0.50 (0.51)	-0.53 (0.59)

6. Other Pre-specified Outcome

Title	Change in Lateral "Wing Beating" Postural Tremor
Description	The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.29 (0.70)	2.16 (0.57)
Change after stimulation	-0.56 (0.72)	-0.36 (0.54)

7. Other Pre-specified Outcome

Title	Change in Lateral "Wing Beating" Postural Tremor
Description	The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and 30 minutes into stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.29 (0.70)	2.16 (0.57)
Change during stimulation	-0.51 (0.70)	-0.34 (0.44)

8. Other Pre-specified Outcome

Title	Change in Forward Outstretched Postural Tremor
Description	The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	1.96 (0.54)	1.91 (0.54)
Change after stimulation	-0.75 (0.65)	-0.35 (0.51)

9. Other Pre-specified Outcome

Title	Change in Forward Outstretched Postural Tremor
Description	The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale. The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.
Time Frame	Immediately before and 30 minutes into stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	1.96 (0.54)	1.91 (0.54)
Change during stimulation	-0.56 (0.59)	-0.35 (0.41)

10. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Use a Spoon to Drink Liquid
Description	The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	3.18 (0.78)	3.00 (0.85)
Change after stimulation	-0.78 (0.89)	-0.59 (0.76)

11. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Hold a Cup of Liquid
Description	The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.95 (0.85)	2.65 (0.92)
Change after stimulation	-1.03 (0.73)	-0.57 (0.80)

12. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Pouring
Description	The change in tremor severity on pouring as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.78 (1.03)	2.59 (0.86)
Change after stimulation	-0.70 (0.76)	-0.59 (0.72)

13. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Dialing
Description	The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.23 (0.89)	2.00 (0.91)
Change after stimulation	-0.70 (0.79)	-0.30 (0.62)

14. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Picking up Change
Description	The change in tremor severity on picking up change as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.03 (0.86)	1.92 (0.89)
Change after stimulation	-0.53 (0.68)	-0.05 (0.62)

15. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Inserting Plug Into Socket
Description	The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	1.83 (0.78)	1.76 (0.80)
Change after stimulation	-0.33 (0.69)	-0.24 (0.55)

16. Other Pre-specified Outcome

Title	Change in Bain & Findley ADL: Unlocking
Description	The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findley ADL rating scale. The Bain and Findley Activities of Daily Living (BF-ADL) assessment evaluates the subject's ability to perform a number of specific ADLs, measured before and after treatment. Each ADL is performed by the subject and self-rated on a scale of 1-4, with higher scores indicating greater difficulty in performing the task.
Time Frame	Immediately before and after 40 minute stimulation session

Outcome Measure Data

Analysis Population Description

Of the 92 subjects that completed the study, 77 were included in the analysis. 15 (8 in the treatment group and 7 in the sham group) were excluded due to significant protocol deviation reasons.

Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description:	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Overall Number of Participants Analyzed	40	37
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	2.23 (0.86)	1.86 (0.67)
Change after stimulation	-0.60 (0.87)	-0.16 (0.55)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	TAPS Stimulation	Sham Stimulation
Arm/Group Description	Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.	0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. Cala ONE Device: The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
All-Cause Mortality
	TAPS Stimulation	Sham Stimulation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	TAPS Stimulation	Sham Stimulation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/48 (0.00%)	0/45 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	TAPS Stimulation	Sham Stimulation
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/48 (4.17%)	1/45 (2.22%)
Nervous system disorders
Feeling of weakness around the wrist	1/48 (2.08%)	0/45 (0.00%)
Skin and subcutaneous tissue disorders
Skin Irritation	2/48 (4.17%)	0/45 (0.00%)
Stinging pain in wrist	0/48 (0.00%)	1/45 (2.22%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Sr. Director of Clinical Operations
• Organization: Cala Health
• Phone: 6506515296
• EMail: vivien@calahealth.com

• Responsible Party: Cala Health, Inc.
• ClinicalTrials.gov Identifier: NCT02629614
• Other Study ID Numbers: ET-03
• First Submitted: December 8, 2015
• First Posted: December 14, 2015
• Results First Submitted: June 1, 2023
• Results First Posted: July 18, 2023
• Last Update Posted: July 18, 2023