Stroke
Conditions
Keywords
transcranial Alternating Current Stimulation, stroke, upper limb, motor recovery
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.
Detailed description
This randomised, double-blinded clinical trial investigates whether transcranial alternating current stimulation (tACS) can improve upper limb motor recovery in chronic stroke patients. Participants receive either active or sham tACS delivered three times weekly for 4-6 weeks (12 sessions total) using individualised stimulation frequencies. The intervention uses 1 mA peak-to-peak intensity with EEG monitoring before and after each session to track brain oscillation changes. Assessments occur at baseline, immediately post-intervention, and one-month follow-up. Neurophysiological measures include transcranial magnetic stimulation evaluations of corticospinal excitability, motor thresholds, and intracortical inhibition. Clinical outcomes encompass the Upper Extremity Fugl-Meyer Assessment, Action Research Arm Test, Modified Ashworth Scale for spasticity, and handgrip strength measurements.
Interventions
DEVICEtACS
. 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.
DEVICESham
Sham mode of the tACS stimulator will be turned on for sham stimulation.
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21-80 years old; 2. First ever stroke, at least 9 months after stroke onset; 3. Evidence of corticomotor excitability as manifested by a recordable Motor Evoked Potential from the ipsilesional Motor Cortex (M1) by TMS measurement. 4. Objectively documented motor weakness of the upper extremity as manifested by an Upper Extremity-Fugl-Meyer Assessment score \<=55
Exclusion criteria
1. 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; 2. Pregnancy; 3. 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; 4. Patients with serious brain injury; 5. Patients showing damage of skin at sites of stimulation; 6. Patients with unstable or non-controlled neuropsychiatric illness; 7. Patients suffering from severe or frequent headaches; 8. Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia; 9. Sensorimotor disturbance due to other causes other than stroke;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremities Fugl-Meyer Assessment (UE-FMA) | Week 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm test (ARAT) | Week 0 | 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 |
| handgrip strength | Week 0 | Hand strength will be measured by a hand-held dynamometer. |
| peak-to-peak amplitude of motor evoked potential (MEP) | Week 0 | Measured by transcranial magnetic stimulation (TMS). Amplitude, latency, resting and active motor thresholds from FDI and APB will be recorded. The bigger value of peak-to peak amplitude of MEP indicates better outcome |
Countries
Singapore
Contacts
CONTACTEffie Chew, MBBS
PRINCIPAL_INVESTIGATOREffie Chew, MBBS
NUH
Outcome results
None listed