Clinical trial NCT05142917: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes of score: Fugl-Meyer Assessment
timeFrame: 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 outcomes:
measure: Changes of score: 9-hole pegboard test
timeFrame: 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: Changes of score: Grip & Tip pinch strength test
timeFrame: 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: Changes in Box & Block test
timeFrame: 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: Changes of score: Jebsen-Taylor hand function test
timeFrame: 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: Changes of score: Korean-Montreal Cognitive Assessment
timeFrame: 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: Changes of score: Korean version of Modified Barthel Index
timeFrame: 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: Changes of score: Geriatric Depression Scale-Short Form
timeFrame: 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: Changes in cortical activity using fNIRS signals
timeFrame: 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 outcomes:
measure: Resting-state functional MRI
timeFrame: Baseline (Before stimulation sessions)
measure: Changes in cortical activity using fNIRS signals
timeFrame: Baseline (Before stimulation sessions)
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: