Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in motor evoked potential
Study Overview
Brief Summary
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unilateral stroke patients
- •Chronic patients over 6 months after onset
- •Patients with motor evoked potential of the first dorsal interosseous muscle
- •Patients with the movement of fingers
Exclusion Criteria
- •History of psychiatric disease
- •Significant other neurological diseases except for stroke
- •Difficult to perform this experiment
- •Patients who are deemed difficult to participate in this research by the investigator
- •Patients with metal implants and medical devices
- •History of epilepsy
- •Pregnancy
- •Skin defect at the site of electrode attachment
Arms & Interventions
Individualized stimulation group
Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation. The simulator generates the electrode's location on the scalp.
Intervention: Transcranial Direct Current Stimulation (Device)
Conventional stimulation group
Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.
Intervention: Transcranial Direct Current Stimulation (Device)
Sham stimulation group
Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.
Intervention: Transcranial Direct Current Stimulation (Device)
Outcomes
Primary Outcomes
Changes in motor evoked potential
Time Frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.
Secondary Outcomes
- Jebsen-Taylor hand function test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- 9-hole peg test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Grip & Tip pinch strength test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Box & Block test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Fugl-Meyer Assessment(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Sequential motor test(Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions))
Investigators
Yun-Hee Kim
Professor
Samsung Medical Center