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tACS for Sensory Motor Recovery After Stroke

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ClinicalTrials.gov Identifier: NCT06029062
Recruitment Status : Not yet recruiting
First Posted : September 8, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Sheng Li, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in stroke survivors.

Condition or disease Intervention/treatment Phase
Motor Recovery Device: tACS Sham Device: tACS 10Hz Device: tACS 20Hz Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
Estimated Study Start Date : September 1, 2024
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: tACS Sham, tACS 10Hz, tACS 20Hz

tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.

tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

 Device: tACS Sham
Sham tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 10Hz
10Hz tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 20Hz
20Hz tACS will applied to the brain through the scalp for 20 minutes.
Experimental: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham

tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.

tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

 Device: tACS Sham
Sham tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 10Hz
10Hz tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 20Hz
20Hz tACS will applied to the brain through the scalp for 20 minutes.
Experimental: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham

tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.

tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

 Device: tACS Sham
Sham tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 10Hz
10Hz tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 20Hz
20Hz tACS will applied to the brain through the scalp for 20 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Block and Box Test (BBT) of Motor functional test [ Time Frame: Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured. ]
    The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick and simple test used with a wide range of populations, including clients with stroke.

  2. EEG alpha band and Beta band [ Time Frame: Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured. ]
    Electroencephalography (EEG) is valuable to infer and evaluate the neural interaction. Components of the alpha and beta frequency bands like the sensorimotor rhythm originated from the primary motor cortex and related brain areas reflect human movement. The power of 8-13 Hz alpha and 14-30 Hz beta frequency bands will be used for the classification.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/exclusion criteria for stroke subjects

Inclusion criteria:

  1. Age between 18~75 years old
  2. ≥ 6 months post stroke, medically stable;
  3. Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
  4. Visible finger flexor activation/movement
  5. The ability to give consent

Exclusion criteria:

  1. Patients with visual deficit/neglect; hearing or cognitive impairment;
  2. Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
  3. Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections <2 years;
  4. Patients with pacemaker, metal implants or supplemental oxygen;
  5. Patients who have musculoskeletal disorders, including pain in the affected side
  6. Women who are pregnant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029062


Contacts
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Contact: Sheng Li, MD, Ph.D (713) 797-7125 sheng.li@uth.tmc.edu
Contact: Shengai Li, MS 713-797-7561 shengai.li@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Contact: Sheng Li, MD, PhD    713-797-7125    sheng.li@uth.tmc.edu   
Contact: Shengai Li, MS    713-797-7561    shengai.li@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sheng Li, MD, Ph.D The University of Texas Health Science Center, Houston
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sheng Li, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT06029062    
Other Study ID Numbers: HSC-MS-22-0046 (Experiment 1)
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sheng Li, The University of Texas Health Science Center, Houston:
tACS
Motor recovery