Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fNIRS based hand motor area real stimulation | Experimental | Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes). |
|
| Traditional hand motor area real stimulation | Active Comparator | Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). |
|
| Traditional hand motor area sham stimulation | Sham Comparator | Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of score: Fugl-Meyer Assessment | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. | 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 | Description | Time Frame |
|---|---|---|
| Changes of score: 9-hole pegboard test | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. | 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 |
| Changes of score: Grip & Tip pinch strength test |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state functional MRI | Before intervention, MRI is acquired to extract brain characteristics of stroke patients. | Baseline (Before stimulation sessions) |
| Changes in cortical activity using fNIRS signals |
Inclusion Criteria:
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
Exclusion criteria for transcranial direct current stimulation:
i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hand motor task | Behavioral | Various type of hand motor tasks are applied to stroke patients. |
|
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. |
| 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 |
| Changes in Box & Block test | The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device. | 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 |
| Changes of score: Jebsen-Taylor hand function test | This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). | 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 |
| Changes of score: Korean-Montreal Cognitive Assessment | This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation. | 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 |
| Changes of score: Korean version of Modified Barthel Index | Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. | 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 |
| Changes of score: Geriatric Depression Scale-Short Form | The test is a self-report measure of depression in older adults. | 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 |
| Changes in cortical activity using fNIRS signals | Cortical activities before, during and after brain stimulation sessions are compared. | 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 |
Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.
| Baseline (Before stimulation sessions) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |