Stroke
Conditions
Brief summary
The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.
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.
BEHAVIORALHand motor task
Various type of hand motor tasks are applied to stroke patients.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 aged 19 to 80 years * Patients with subacute stroke within 4 weeks of onset * Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation
Exclusion criteria
* Accompanied by an existing serious neurogenic disease * Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia. * If there are difficulties in conducting the research * Any patients who are judged by the investigator to be difficult to participate in this study *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of score: Fugl-Meyer Assessment | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of score: 9-hole pegboard test | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. |
| Changes of score: Grip & Tip pinch strength test | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. |
| Changes in Box & Block test | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device. |
| Changes of score: Jebsen-Taylor hand function test | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). |
| Changes of score: Geriatric Depression Scale-Short Form | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | The test is a self-report measure of depression in older adults. |
| Changes in cortical activity using fNIRS signals | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | Cortical activities before, during and after brain stimulation sessions are compared. |
| Changes of score: Korean-Montreal Cognitive Assessment | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation. |
| Changes of score: Korean version of Modified Barthel Index | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resting-state functional MRI | Baseline (Before stimulation sessions) | Before intervention, MRI is acquired to extract brain characteristics of stroke patients. |
| Changes in cortical activity using fNIRS signals | Baseline (Before stimulation sessions) | Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients. |
Countries
South Korea
Outcome results
None listed