Stroke
Conditions
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.
Interventions
DEVICETranscranial Direct Current Stimulation
Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Sponsors
Pusan National University Yangsan Hospital
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in motor evoked potential | 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
| Measure | Time frame | Description |
|---|---|---|
| 9-hole peg test | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. |
| Grip & Tip pinch strength test | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. |
| Jebsen-Taylor hand function test | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). |
| Fugl-Meyer Assessment | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. |
| 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) | Response time and accuracy are measured during finger tapping task. |
| Box & Block test | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device. |
Countries
South Korea
Outcome results
None listed