About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

34 Participants

are divided into 2 treatment groups

Group A: real tACSActive comparator 1 intervention

Group B: sham tACSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Week 0

2

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.

Time frame

Week 6

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.

Time frame

Week 10

Secondary outcomes

1

Action Research Arm test (ARAT)

ARAT evaluates UL motor function and status in standardized format using 19 tests of upper UE motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke

Time frame

Week 0

2

Action Research Arm test (ARAT)

ARAT evaluates UL motor function and status in standardized format using 19 tests of upper UE motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke

Time frame

Week 6

3

Action Research Arm test (ARAT)

ARAT evaluates UL motor function and status in standardized format using 19 tests of upper UE motor function across 4 subsets: grasp, pinch, grip, and gross movement, both distally and proximally, following a stroke

Time frame

Week 10

4

handgrip strength

Hand strength will be measured by a hand-held dynamometer.

Time frame

Week 0

tACS and Upper Limb Rehabilitation in Chronic Stroke

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts