tACS for Sensory Motor Recovery After Stroke

Motor Recovery Clinical Trial

Official title:

tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029062
• Other study ID #: HSC-MS-22-0046 (Experiment 1)
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Sheng Li, MD, Ph.D
• Phone: (713) 797-7125
• Email: sheng.li[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: March 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Recovery

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block and Box Test (BBT) of Motor functional test	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.
Primary	EEG alpha band and Beta band	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.