Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT04877015
• Recruitment Status: Terminated
• First Posted: May 7, 2021
• Last Update Posted: December 27, 2022
• Sponsor: Synergic Medical Technologies, Inc.
• Collaborator: Stanford University
• Information provided by (Responsible Party): Synergic Medical Technologies, Inc.

Tracking Information

• First Submitted Date: April 30, 2021
• First Posted Date: May 7, 2021
• Last Update Posted Date: December 27, 2022
• Actual Study Start Date: December 7, 2021
• Actual Primary Completion Date: October 14, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2021)

Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 [ Time Frame: 14months ]

This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. This evaluation will be done in person at baseline, 3,6 and 7 months. The remote version will be done at 10, 13 and 14 months

Original Primary Outcome Measures (submitted: May 3, 2021)

Movement Disorders Society Unified Parkinson Disease Rating Scale [ Time Frame: 13 months ]

Parkinsons movement evaluation

Current Secondary Outcome Measures (submitted: December 22, 2022)

• Spontaneous electroencephalography (EEG) [ Time Frame: 7 months ]
  Spontaneous EEG is recorded at baseline, 3, 6 and 7 months. 3 types of recordings will occur per visit:5 minute Baseline, 16 minute during vibrotactile therapy (sham or active vCR depending on the participant group) and post vibrotactile therapy. Power spectral density (PSD) will be calculated from source constructed EEG activity for each frequency band of interest (Delta: 2-4 Hz; Theta: 5-7 Hz; Alpha: 8-12 Hz; Low Beta: 13-16 Hz; Mid Beta: 17-20 Hz; High Beta: 21-30 Hz; and Gamma: 31-50 Hz) using the Welch method with a 2-s window overlapping by 50%. Relative power (RP) is calculated by taking the sum of each frequency band and dividing it by the total power across the spectrum (2-50 Hz).
• Sensorimotor task EEG [ Time Frame: 7 months ]
  Sensorimotor activity during the EEG will be recorded at baseline, 3, 6 and 7 months. Patients receive a single vibratory stimulus to a random finger (excluding the thumb) on their left or right hand and are instructed with their non-stimulated hand to push the response button as fast as possible when they feel the vibratory burst. Each finger receives an equal number of vibratory pulses (50 per finger, equaling 200 trials per hand) in a randomized order. Cortically, we expect to look at motor evoked potentials in response to cued vibration by means of their amplitude (micro-volts) and latency (time in milliseconds) and their changes throughout the course of treatment. Reaction time (in milliseconds) will also be documented.
• Vibration-only evoked EEG potentials [ Time Frame: 7 months ]
  We will record vibration-only evoked EEG potentials at baseline, 3, 6 and 7 months.We will look at how single vibratory pulses to each finger (excluding the thumb) affect different motor and sensory areas of the brain.Each finger receives an equal number of vibratory pulses (50 per finger, equaling 200 trials per hand) in a randomized order. Cortically, we expect to look at sensory evoked potentials in response to vibration by means of their amplitude (micro-volts) and latency (time in milliseconds) and their changes throughout the course of treatment.
• PD Quality of Life Questionnaire-39 (PDQ-39) [ Time Frame: 14 months ]
  The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems. This questionnaire will be taken at baseline, 3, 6, 7, 10, 13 and 14 months.
• Parkinson's disease sleep scale (PDSS) [ Time Frame: 14 months ]
  The Parkinson's disease sleep scale (PDSS) is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance in the past week. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum cumulative score for the PDSS is 150 This questionnaire will be taken at baseline, 3, 6, 7, 10, 13 and 14 months.
• University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: 7 months ]
  University of Pennsylvania Smell Identification Test (UPSIT) is a smell test comprised of 40 odors, in which patients try to correctly identify the odor presented. The test is a forced choice paradigm, that is, if an individual is unsure of an answer they are forced to guess a response hence a score of 25% on average would reflect random guessing. An UPSIT result is scored out of 40 where a higher score indicates better olfaction.This test will be taken at baseline, 3, 6, and 7 months
• Vibratory temporal discrimination task (VTDT) [ Time Frame: 7 months ]
  The vibratory temporal discrimination task (VTDT) consists of two vibratory bursts, with one burst delivered to the index finger and one burst to the middle finger. This procedure will be performed on the right and left hand separately. The patient is instructed to judge if he/she felt a delay between the two vibratory bursts. This task was designed as a possible calibration method for future vCR studies by serving as a sensitivity measure for vibratory temporal changes, in which reduced perceived vibratory time differences (in milliseconds) correspond to increased vibratory temporal discrimination. This task will be done at at baseline, 3, 6 and 7 months.
• Speech and voice assessments [ Time Frame: 7 months ]
  To collect samples, a head-worn, unidirectional microphone will be placed over the participant's ears and the microphone will be adjusted so that it is 6 cm from the participant's mouth. Specific samples will include sustained vowel phonations, sentence and paragraph length reading passages, and spontaneous speech. From these samples, speech and voice assessments will be conducted including measures of articulatory precision, speech intelligibility, speech rate, auditory-perceptual ratings of voice, and acoustic measures of vocal fundamental frequency, vocal intensity, and fundamental frequency and intensity variability. The speech and voice evaluation will be done at baseline, 3, 6 and 7 months
• Kinesia One motor evaluation [ Time Frame: 14 months ]
  The Kinesia One motor evaluation, which uses a wearable accelerometer to assess Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities). Patients will perform this test at baseline, 3, 6,7 months in person and at home at 10, 13 and 14 months.
• Levodopa equivalent daily dose (LEDD) [ Time Frame: 14 months ]
  Levodopa equivalent daily dose (LEDD) will measured at baseline, 3,6,7,10,13 and 14 months. LEDD is calculated as a sum of each Parkinson's medication.
• Freezing of Gait Questionnaire [ Time Frame: 14 months ]
  The Freezing of Gait Questionnaire (FOGQ) assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The FOG is comprised of 6 questions measured on a 0 to 4 scale (where 0 is normal and 4 represents severe abnormalities). The scores are summed together with 0 representing the best possible score and 24 representing the worst possible score. FOG will measured at baseline, 3,6,7,10,13 and 14 month

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
• Official Title: Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
• Brief Summary: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.
• Detailed Description: Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease

Intervention

• Device: Active Vibrotactile Coordinated Reset (vCR)
  Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.
  Other Name: VT Brain Glove
• Device: Sham Vibrotactile Coordinated Reset (vCR)
  Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.
  Other Name: VT Brain Glove

Study Arms

• Active Comparator: Active Vibrotactile Coordinated Reset (vCR)
  Participants in this arm will receive active vCR stimulation.
  Intervention: Device: Active Vibrotactile Coordinated Reset (vCR)
• Sham Comparator: Sham Vibrotactile Coordinated Reset (vCR)
  Participants in this arm will receive sham vCR stimulation.
  Intervention: Device: Sham Vibrotactile Coordinated Reset (vCR)

• Publications *: Pfeifer KJ, Cook AJ, Yankulova JK, Mortimer BJP, Erickson-DiRenzo E, Dhall R, Montaser-Kouhsari L, Tass PA. Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Front Neurol. 2021 Nov 18;12:758481. doi: 10.3389/fneur.2021.758481. eCollection 2021.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 24, 2022): 36
• Original Estimated Enrollment (submitted: May 3, 2021): 30
• Actual Study Completion Date: October 14, 2022
• Actual Primary Completion Date: October 14, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

1. Between the ages of 45-85
2. Diagnosis of idiopathic Parkinson's disease
3. Bilateral impairment, as defined as Hoehn & Yahr Stages II-IV in the on-medication state
4. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor improvement greater than or equal to 30% when on medication compared to when off medication.
5. Participants must be on stable dose of dopaminergic medication for 1 month prior to baseline visit.
6. Able to provide informed consent.
7. Appropriate social support if required during an off state.
8. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
9. Participants must speak English and can communicate with staff without the need of an interpreter.
10. If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recordings

Exclusion Criteria

1. Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication-induced parkinsonism, and vascular parkinsonism.
2. Presence of other brain diseases (i.e. major depression, dementia, Attention Deficit/Hyperactivity Disorder (ADHD) psychosis, etc…).
3. Severe depression, severe anxiety, or severe psychosis for the purpose of excluding candidates at an elevated risk of suicidal tendencies.
4. Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
5. Physical limitations unrelated to Parkinson's disease.
6. Speech problems or excessive drooling so severe patient cannot communicate properly to staff.
7. Presences of dopamine dysregulation syndrome.
8. On dopamine agonist(s) and exhibits compulsive behaviors.
9. Current delirium
10. Pregnancy, breastfeeding, or trying to get pregnant during the duration of the study.
11. History of epilepsy or traumatic brain injury.
12. Brain surgery (i.e. DBS implantation) or craniotomy.
13. Neurostimulator.
14. A type of hairstyle that would impede the use of a EEG cap
15. Severe sensory abnormalities of the fingertips such as vibratory urticaria.
16. Current or ongoing hallucinations, delusions.
17. The PI and study's neurologist deems the patient ineligible.
18. Patient has a functional movement disorder that prevents accurate Parkinson's disease evaluations

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04877015
• Other Study ID Numbers: 59621
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Potentially available upon request.

• Current Responsible Party: Synergic Medical Technologies, Inc.
• Original Responsible Party: Peter Tass, Stanford University, Professor
• Current Study Sponsor: Synergic Medical Technologies, Inc.
• Original Study Sponsor: Stanford University
• Collaborators: Stanford University

Investigators

• Principal Investigator: Peter Tass, MD PhD; Stanford University

• PRS Account: Synergic Medical Technologies, Inc.
• Verification Date: December 2022