Back to resultsThe Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Hand motor task
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
fNIRS based hand motor area real stimulation
Traditional hand motor area real stimulation
Traditional hand motor area sham stimulation
Arm Description
Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).
Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes of score: 9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Changes of score: Grip & Tip pinch strength test
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
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.
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).
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.
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.
Changes of score: Geriatric Depression Scale-Short Form
The test is a self-report measure of depression in older adults.
Changes in cortical activity using fNIRS signals
Cortical activities before, during and after brain stimulation sessions are compared.
Full Information
NCT ID
NCT05142917
First Posted
November 28, 2021
Last Updated
February 27, 2023
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05142917
Brief Title
The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
Official Title
The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
January 8, 2023 (Actual)
Study Completion Date
January 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fNIRS based hand motor area real stimulation
Arm Type
Experimental
Arm Description
Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).
Arm Title
Traditional hand motor area real stimulation
Arm Type
Active Comparator
Arm Description
Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
Arm Title
Traditional hand motor area sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Intervention Type
Behavioral
Intervention Name(s)
Hand motor task
Intervention Description
Various type of hand motor tasks are applied to stroke patients.
Primary Outcome Measure Information:
Title
Changes of score: Fugl-Meyer Assessment
Description
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
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
Secondary Outcome Measure Information:
Title
Changes of score: 9-hole pegboard test
Description
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
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
Title
Changes of score: Grip & Tip pinch strength test
Description
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
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
Title
Changes in Box & Block test
Description
The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
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
Title
Changes of score: Jebsen-Taylor hand function test
Description
This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
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
Title
Changes of score: Korean-Montreal Cognitive Assessment
Description
This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation.
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
Title
Changes of score: Korean version of Modified Barthel Index
Description
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.
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
Title
Changes of score: Geriatric Depression Scale-Short Form
Description
The test is a self-report measure of depression in older adults.
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
Title
Changes in cortical activity using fNIRS signals
Description
Cortical activities before, during and after brain stimulation sessions are compared.
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
Other Pre-specified Outcome Measures:
Title
Resting-state functional MRI
Description
Before intervention, MRI is acquired to extract brain characteristics of stroke patients.
Time Frame
Baseline (Before stimulation sessions)
Title
Changes in cortical activity using fNIRS signals
Description
Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.
Time Frame
Baseline (Before stimulation sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
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