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

NCT05142917 | Completed

• 1 other identifier: 2021-10-092-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (8)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (2)

• Resting-state functional MRI

  Baseline (Before stimulation sessions)

• Changes in cortical activity using fNIRS signals

  Baseline (Before stimulation sessions)

Study Arms (3)

fNIRS based hand motor area real stimulation

EXPERIMENTAL

Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).

Device: Transcranial Direct Current Stimulation; Behavioral: Hand motor task

Traditional hand motor area real stimulation

ACTIVE COMPARATOR

Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Device: Transcranial Direct Current Stimulation; Behavioral: Hand motor task

Traditional hand motor area sham stimulation

SHAM COMPARATOR

Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Behavioral: Hand motor task

Interventions

Transcranial Direct Current Stimulation DEVICE

Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Traditional hand motor area real stimulation; fNIRS based hand motor area real stimulation

Hand motor task BEHAVIORAL

Various type of hand motor tasks are applied to stroke patients.

Traditional hand motor area real stimulation; Traditional hand motor area sham stimulation; fNIRS based hand motor area real stimulation

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 3, 2021
• Study Start: February 11, 2022
• Primary Completion: January 8, 2023
• Study Completion: January 8, 2023
• Last Updated: March 1, 2023

Record last verified: 2021-11

Locations

KR (1)