Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT04699331
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Study Start: 2021-01-29
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Unilateral stroke patients
• Chronic patients over 6 months after onset
• Patients with motor evoked potential of the first dorsal interosseous muscle
• Patients with the movement of fingers

Exclusion Criteria

• History of psychiatric disease
• Significant other neurological diseases except for stroke
• Difficult to perform this experiment
• Patients who are deemed difficult to participate in this research by the investigator
• Patients with metal implants and medical devices
• History of epilepsy
• Pregnancy
• Skin defect at the site of electrode attachment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional stimulation group	Transcranial Direct Current Stimulation	Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.
Individualized stimulation group	Transcranial Direct Current Stimulation	Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation. The simulator generates the electrode's location on the scalp.
Sham stimulation group	Transcranial Direct Current Stimulation	Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.

Primary Outcome Measures

Name	Time	Method
Changes in motor evoked potential	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)	Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the 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. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.

Secondary Outcome Measures

Name	Time	Method
Jebsen-Taylor hand function test	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)	This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
9-hole peg test	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Grip & Tip pinch strength test	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)	The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Box & Block test	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)	The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
Fugl-Meyer Assessment	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)	The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Sequential motor test	Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)	Response time and accuracy are measured during finger tapping task.

Trial Locations

Locations (1)

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