tACS for Sensory Motor Recovery After Stroke

tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments

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

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured.
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.
Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sheng Li, MD, Ph.D, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-22-0046 (Experiment 1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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