The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: fNIRS based hand motor area real stimulation Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes). |
Device: Transcranial 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.
Behavioral: Hand motor task
Various type of hand motor tasks are applied to stroke patients.
|
| Active Comparator: Traditional hand motor area real stimulation Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). |
Device: Transcranial 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.
Behavioral: Hand motor task
Various type of hand motor tasks are applied to stroke patients.
|
| Sham Comparator: Traditional hand motor area sham stimulation Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). |
Behavioral: Hand motor task
Various type of hand motor tasks are applied to stroke patients.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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: 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.
- 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.
Other Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unilateral stroke patients aged 19 to 80 years
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Patients with subacute stroke within 4 weeks of onset
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Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation
Exclusion Criteria:
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Accompanied by an existing serious neurogenic disease
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Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
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If there are difficulties in conducting the research
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Any patients who are judged by the investigator to be difficult to participate in this study
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Exclusion criteria for transcranial direct current stimulation:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-10-092-001