NCT06029062

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Sep 2025Mar 2028

First Submitted

Initial submission to the registry

May 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

May 10, 2023

Last Update Submit

February 20, 2025

Conditions

Keywords

tACSMotor recovery

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (3)

tACS Sham, tACS 10Hz, tACS 20Hz

EXPERIMENTAL

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 ShamDevice: tACS 10HzDevice: tACS 20Hz

HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham

EXPERIMENTAL

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 ShamDevice: tACS 10HzDevice: tACS 20Hz

HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham

EXPERIMENTAL

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 ShamDevice: tACS 10HzDevice: tACS 20Hz

Interventions

tACS ShamDEVICE

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

HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS ShamHD-tACS 20Hz, HD-tACS 10Hz, HD-tACS ShamtACS Sham, tACS 10Hz, tACS 20Hz
tACS 10HzDEVICE

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

HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS ShamHD-tACS 20Hz, HD-tACS 10Hz, HD-tACS ShamtACS Sham, tACS 10Hz, tACS 20Hz
tACS 20HzDEVICE

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

HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS ShamHD-tACS 20Hz, HD-tACS 10Hz, HD-tACS ShamtACS Sham, tACS 10Hz, tACS 20Hz

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Study Officials

  • Sheng Li, MD, Ph.D

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Li, MD, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

September 8, 2023

Study Start

September 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations