tACS for Sensory Motor Recovery After Stroke

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06029062
Collaborator
(none)
14
1
3
46
0.3

Study Details

Study Description

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
  • Device: tACS Sham
  • Device: tACS 10Hz
  • Device: tACS 20Hz
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

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

Primary Outcome Measures

  1. Block and Box Test (BBT) of Motor functional test [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 [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

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Sheng Li, Professor, The University of Texas Health Science Center, Houston

Study Results

No Results Posted as of Sep 8, 2023