- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06029062
tACS for Sensory Motor Recovery After Stroke
tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shengai Li, MS
- Phone Number: 713-797-7561
- Email: shengai.li@uth.tmc.edu
Study Contact Backup
- Name: Sheng Li, MD, Ph.D
- Phone Number: (713) 797-7125
- Email: sheng.li@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center
-
Contact:
- Sheng Li, MD, PhD
- Phone Number: (713) 797-7125
- Email: sheng.li@uth.tmc.edu
-
Contact:
- Shengai Li, MS
- Phone Number: 713-797-7561
- Email: shengai.li@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion/exclusion criteria for stroke subjects
Inclusion criteria:
- Age between 18~75 years old
- ≥ 6 months post stroke, medically stable;
- Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
- Visible finger flexor activation/movement
- The ability to give consent
Exclusion criteria:
- Patients with visual deficit/neglect; hearing or cognitive impairment;
- Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
- Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections <2 years;
- Patients with pacemaker, metal implants or supplemental oxygen;
- Patients who have musculoskeletal disorders, including pain in the affected side
- Women who are pregnant.
Study Plan
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
Investigators
- Principal Investigator: Sheng Li, MD, Ph.D, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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