The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
February 27, 2023 updated by: Samsung Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Various type of hand motor tasks are applied to stroke patients.
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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).
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Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Various type of hand motor tasks are applied to stroke patients.
|
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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).
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Various type of hand motor tasks are applied to stroke patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes of score: Fugl-Meyer Assessment
Time Frame: 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
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The score is a stroke-specific, performance-based impairment index.
The degree of impairment of upper and lower limbs is measured.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes of score: 9-hole pegboard test
Time Frame: 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
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The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
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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
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Changes of score: Grip & Tip pinch strength test
Time Frame: 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
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The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
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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
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Changes in Box & Block test
Time Frame: 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
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The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
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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
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Changes of score: Jebsen-Taylor hand function test
Time Frame: 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
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This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
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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
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Changes of score: Korean-Montreal Cognitive Assessment
Time Frame: 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
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This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation.
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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
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Changes of score: Korean version of Modified Barthel Index
Time Frame: 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
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Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.
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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
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Changes of score: Geriatric Depression Scale-Short Form
Time Frame: 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
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The test is a self-report measure of depression in older adults.
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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
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Changes in cortical activity using fNIRS signals
Time Frame: 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
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Cortical activities before, during and after brain stimulation sessions are compared.
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resting-state functional MRI
Time Frame: Baseline (Before stimulation sessions)
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Before intervention, MRI is acquired to extract brain characteristics of stroke patients.
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Baseline (Before stimulation sessions)
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Changes in cortical activity using fNIRS signals
Time Frame: Baseline (Before stimulation sessions)
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Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.
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Baseline (Before stimulation sessions)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2022
Primary Completion (Actual)
January 8, 2023
Study Completion (Actual)
January 8, 2023
Study Registration Dates
First Submitted
November 28, 2021
First Submitted That Met QC Criteria
December 1, 2021
First Posted (Actual)
December 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-10-092-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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