A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Sep 2020
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2020
CompletedMarch 10, 2021
September 1, 2020
3 months
September 2, 2020
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in cortical activity using fNIRS signals during brain stimulation
Cortical activities before and after brain stimulation sessions are compared.
Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary Outcomes (6)
Changes in motor evoked potential
Baseline and about 10 days (immediately after brain stimulation sessions)
9-hole pegboard test
Baseline and about 10 days (immediately after brain stimulation sessions)
Grip & Tip pinch strength test
Baseline and about 10 days (immediately after brain stimulation sessions)
Box & Block test
Baseline and about 10 days (immediately after brain stimulation sessions)
Fugl-Meyer Assessment
Baseline and about 10 days (immediately after brain stimulation sessions)
- +1 more secondary outcomes
Study Arms (1)
tDCS stimulation group
EXPERIMENTALPatients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system.
Interventions
Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system
Eligibility Criteria
You may qualify if:
- Unilateral stroke patients
- Chronic patients over 6 months after onset
- Subcortical stroke
- Patients with the movement of fingers
You may not qualify if:
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- Patients with metal implants
- History of epilepsy
- Pregnancy
- Skin defect at the site of electrode attachment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 16, 2020
Study Start
September 15, 2020
Primary Completion
December 10, 2020
Study Completion
December 10, 2020
Last Updated
March 10, 2021
Record last verified: 2020-09