Effects of Transcranial Electrical Stimulation in Stroke Individuals

NCT06134921 | Completed

• 1 other identifier: MU-CIRB 2023/288.1509
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will use transcranial electrical stimulation (tES) with conventional physical therapy in sub-acute (at least 2 weeks after stroke onset) to chronic stroke within 2 years to investigate the effect on cortical activity and upper and lower limb motor function. The findings may support the usage of tES for improving brain activity and motor function in a clinic setting.

Conditions

Chronic Stroke; Subacute Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

transcranial electrical stimulation; stroke; electroencephalography; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA) of upper and lower extremities

  The Fugl-Meyer Assessmen is used to quantify motor impairment and recovery post-stroke. The participants will use their unaffected side to perform first, and then subsequently perform their affected side in each movement 3 times. The best movement will be scored. The best performance was scored through direct observation as follows: 0=could not perform, 1= performed partially, and 2= performed fully. There was a total score of 100 (66 and 34 points for the upper and lower limbs, respectively

  Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

Secondary Outcomes (8)

• Brain symmetry index (BSI)

  Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

• Absolute power

  Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

• Timed Up and Go test

  Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

• Five-Time Sit to Stand Test

  Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

• Spatiotemporal gait variables

  Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention

Study Arms (3)

Active tDCS and conventional physical therapy program

EXPERIMENTAL

Participants will receive Active tDCS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.

Device: transcranial direct current stimulation (Active); Other: Conventional physical therapy program

Active tACS and conventional physical therapy program

EXPERIMENTAL

Participants will receive Active tACS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.

Device: transcranial alternating current stimulation (active); Other: Conventional physical therapy program

Sham stimulation and conventional physical therapy program

SHAM COMPARATOR

Participants will receive sham stimulation for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.

Device: transcranial electrical stimulation (sham); Other: Conventional physical therapy program

Interventions

transcranial direct current stimulation (Active) DEVICE

Electrode placement based on the international 10 - 20 electroencephalography electrode system for the cathodal electrode will be applied over the contralesional hemisphere. In contrast, an anodal electrode will be applied over the ipsilesional hemisphere on the primary motor cortex (C3 or C4). Participants will be asked to sit comfortably during stimulation. In the Active-tDCS group, participants will receive real tDCS with intensity 2.0 mA for 30 minutes, with a 30-second ramp-up and ramp-down.

Also known as: tDCS (Active), innk; Neurophet, Korea

Active tDCS and conventional physical therapy program

transcranial alternating current stimulation (active) DEVICE

Electrode placement based on the international 10 - 20 electroencephalography electrode system for the cathodal electrode will be applied over the contralesional hemisphere. In contrast, an anodal electrode will be applied over the ipsilesional hemisphere on the primary motor cortex (C3 or C4). Participants will be asked to sit comfortably during stimulation.

Also known as: tACS (Active), innk; Neurophet, Korea

Active tACS and conventional physical therapy program

transcranial electrical stimulation (sham) DEVICE

Electrode placement based on the international 10 - 20 electroencephalography electrode system for applied the cathodal electrode will be applied over the contralesional hemisphere. In contrast, an anodal electrode will be applied over the ipsilesional hemisphere on the primary motor cortex (C3 or C4). Participants will be asked to sit comfortably during stimulation. In the Sham group, participants will receive sham stimulation with intensity 2.0 mA for 1 minute, with a 30-second ramp-up and ramp-down, and no stimulation until the end of 30 minutes of stimulation. Electrodes will remain for 30 minutes.

Also known as: Sham stimulation, innk; Neurophet, Korea

Sham stimulation and conventional physical therapy program

Conventional physical therapy program OTHER

A conventional physical therapy program will be provided after 30 minutes of stimulation immediately. The program will be provided for both upper and lower limbs which consist of stretching exercise, active exercise, and functional exercise.

Active tACS and conventional physical therapy program; Active tDCS and conventional physical therapy program; Sham stimulation and conventional physical therapy program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke individuals aged 18 - 80 years.
• A first-ever unilateral ischemic or hemorrhagic stroke.
• Stroke onset from at least 2 weeks - 2 years.
• Having modified Rankin scale (mRS) 1-4
• Ability to communicate, follow, and understand the instruction.

You may not qualify if:

• Presence of any neurological antecedent, unstable medical conditions or condition that may increase risk of stimulation such as epilepsy and seizure, and history of brain surgery.
• Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
• Presence of opened wound or infectious wound around the scalp.
• Moderate pain in any joint of the upper or lower paretic limb (numerical pain rating score \> 4/10).
• History of receiving non-invasive brain stimulation within the past 6 months.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Nakonpathom, 73170, Thailand

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2023
• Primary Completion: December 30, 2024
• Study Completion: April 30, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)