Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tDCS stimulation with hand task
sham tDCS stimulation with hand task
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Patients aged 19 to 80 years
- Less than 58 FMA Upper scores
- Patients whose lesions do not include stimulation regions
- Patients with stroke with more than 3 months of onset
Exclusion Criteria:
- Difficult to communicate due to severe language impairment.
- Accompanied by an existing serious neurogenic disease
- Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
- If there are difficulties in conducting the research
- Any patients who are judged by the investigator to be difficult to participate in this study
- Patients with contraindicated MRI scans
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hand Tasks + M1(1mA) & aIPS(1mA) tDCS
Hand Tasks + Sham tDCS
Arm Description
20 minutes of Hand Taks + applying 30 minutes of M1(1mA) & aIPS(1mA) tDCS and fNIRS
20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS
Outcomes
Primary Outcome Measures
Change in 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
Change in 9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Change in Grip & Tip pinch strength
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Change in Sequential finger tapping reaction time and accruacy
Response time and accuracy are measured during finger tapping task.
Change in 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).
Change in Box and 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 in motor evoked potential
Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.
Changes in Brain activation of resting-state functional MRI
Measure of Neuroplasticity
Full Information
NCT ID
NCT05275114
First Posted
March 1, 2022
Last Updated
September 20, 2022
Sponsor
Yun-Hee Kim
Collaborators
Cybermedic Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05275114
Brief Title
Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
Official Title
Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yun-Hee Kim
Collaborators
Cybermedic Co., Ltd.
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 was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and 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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand Tasks + M1(1mA) & aIPS(1mA) tDCS
Arm Type
Experimental
Arm Description
20 minutes of Hand Taks + applying 30 minutes of M1(1mA) & aIPS(1mA) tDCS and fNIRS
Arm Title
Hand Tasks + Sham tDCS
Arm Type
Active Comparator
Arm Description
20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS
Intervention Type
Device
Intervention Name(s)
tDCS stimulation with hand task
Intervention Description
30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
Intervention Type
Device
Intervention Name(s)
sham tDCS stimulation with hand task
Intervention Description
30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
Primary Outcome Measure Information:
Title
Change in 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
Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)
Secondary Outcome Measure Information:
Title
Change in 9-hole pegboard test
Description
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Time Frame
Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Title
Change in Grip & Tip pinch strength
Description
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Time Frame
Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Title
Change in Sequential finger tapping reaction time and accruacy
Description
Response time and accuracy are measured during finger tapping task.
Time Frame
Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Title
Change in 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(initial visit); Session 10 (at approximatel 4 weeks)
Title
Change in Box and 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(initial visit); Session 10 (at approximatel 4 weeks)
Title
Changes in motor evoked potential
Description
Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.
Time Frame
[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]
Title
Changes in Brain activation of resting-state functional MRI
Description
Measure of Neuroplasticity
Time Frame
[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]
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:
Patients aged 19 to 80 years
Less than 58 FMA Upper scores
Patients whose lesions do not include stimulation regions
Patients with stroke with more than 3 months of onset
Exclusion Criteria:
Difficult to communicate due to severe language impairment.
Accompanied by an existing serious neurogenic disease
Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
If there are difficulties in conducting the research
Any patients who are judged by the investigator to be difficult to participate in this study
Patients with contraindicated MRI scans
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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Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function
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