tACS and Upper Limb Rehabilitation in Chronic Stroke

NCT07778342 | Not Yet Recruiting

• 1 other identifier: 2024/3852
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether a brain stimulation technique called tACS can help stroke patients recover movement in their affected arm. Patients receive either real or fake brain stimulation three times a week for about a month (12 sessions total). During each session, they wear a cap with electrodes that deliver mild electrical currents tailored to their individual brain patterns, while researchers monitor their brain activity. The study measures progress at three time points: before treatment, right after treatment, and one month later. Researchers use brain stimulation tests to check how well the brain controls muscles, and conduct physical tests to measure arm movement, muscle stiffness, and grip strength.

Conditions

Stroke

Keywords

transcranial Alternating Current Stimulation; stroke; upper limb; motor recovery

Outcome Measures

Primary Outcomes (3)

• Upper Extremities Fugl-Meyer Assessment (UE-FMA)

  UE-FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

  Week 0

• Upper Extremities Fugl-Meyer Assessment (UE-FMA)

  UE-FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

  Week 6

• Upper Extremities Fugl-Meyer Assessment (UE-FMA)

  UE-FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

  Week 10

Secondary Outcomes (9)

• Action Research Arm test (ARAT)

  Week 0

• Action Research Arm test (ARAT)

  Week 6

• Action Research Arm test (ARAT)

  Week 10

• handgrip strength

  Week 0

• handgrip strength

  Week 6

Study Arms (2)

real tACS

ACTIVE COMPARATOR

tACS will be delivered at a maximum intensity of 1 mA (peak-to-peak) at a frequency corresponding to the individual peak motor imagery (MI) performance frequency.

Device: tACS

sham tACS

SHAM COMPARATOR

sham tACS mimics active stimulation by delivering short periods of current matching the active protocol) with brief ramp-up and ramp-down periods at the very beginning and end of the session to replicate initial skin tingling sensations.

Device: Sham

Interventions

tACS DEVICE

. tACS will be delivered at a maximum intensity of 1 mA (peak-to-peak) at a frequency corresponding to the individual peak motor imagery (MI) performance frequency. 12 sessions of tACS will be conducted 3 times a week within 4-6 weeks.

real tACS

Sham DEVICE

Sham mode of the tACS stimulator will be turned on for sham stimulation.

sham tACS

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-80 years old;
• First ever stroke, at least 9 months after stroke onset;
• Evidence of corticomotor excitability as manifested by a recordable Motor Evoked Potential from the ipsilesional Motor Cortex (M1) by TMS measurement.
• Objectively documented motor weakness of the upper extremity as manifested by an Upper Extremity-Fugl-Meyer Assessment score \<=55

You may not qualify if:

• Patients with implants: cardiac, neural or medication implants; any electrically, magnetically or mechanically activated implant; brain medical devices; vascular clips or any other electrically sensitive support system in the brain; other metal implants inside the body that are contraindications of MRI scan;
• Pregnancy;
• Patients with a history of seizures; Patients with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy;
• Patients with serious brain injury;
• Patients showing damage of skin at sites of stimulation;
• Patients with unstable or non-controlled neuropsychiatric illness;
• Patients suffering from severe or frequent headaches;
• Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia;
• Sensorimotor disturbance due to other causes other than stroke;

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Alexandra Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Effie Chew, MBBS

  NUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Effie Chew, MBBS

CONTACT

+65 9365 3542; effie_chew@nuhs.edu.sg

Study Design

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

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)