The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Transcranial Direct Current Stimulation; Behavioral: Hand motor task

• Registration Number: NCT05142917
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-28
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-03
• Study Start: 2022-02-11
• Primary Completion: 2023-01-08
• Study Completion: 2023-01-08
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fNIRS based hand motor area real stimulation	Hand motor task	Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).
fNIRS based hand motor area real stimulation	Transcranial Direct Current Stimulation	Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).
Traditional hand motor area real stimulation	Hand motor task	Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
Traditional hand motor area real stimulation	Transcranial Direct Current Stimulation	Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
Traditional hand motor area sham stimulation	Hand motor task	Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Primary Outcome Measures

Name	Time	Method
Changes of score: Fugl-Meyer Assessment	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	The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

Secondary Outcome Measures

Name	Time	Method
Changes in Box & Block test	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	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: Geriatric Depression Scale-Short Form	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	The test is a self-report measure of depression in older adults.
Changes of score: 9-hole pegboard test	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	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Changes of score: Korean version of Modified Barthel Index	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 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: Korean-Montreal Cognitive Assessment	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	This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation.
Changes of score: Grip & Tip pinch strength test	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	The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Changes of score: Jebsen-Taylor hand function test	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	This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
Changes in cortical activity using fNIRS signals	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	Cortical activities before, during and after brain stimulation sessions are compared.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of