The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients

Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation; Behavioral: Motor learning

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral stroke including basal ganglia lesion patients
• Chronic patients over 6 months after onset
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real stimulation before motor learning training; Patients receive five sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.	Device: Transcranial Direct Current Stimulation; Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.; Behavioral: Motor learning; Sequential finger tapping task training is applied to stroke patients.
Active Comparator: Sham stimulation before motor learning training; Patients receive five sessions of sham stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.	Behavioral: Motor learning; Sequential finger tapping task training is applied to stroke patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, immediately after five brain stimulation sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cortical activity using fNIRS signals during brain stimulation	Cortical activities before, during and after brain stimulation sessions are compared.	Baseline, during, immediately after five brain stimulation sessions
Changes in motor evoked potential	Resting motor threshold (rMT) and amplitude of motor evoked potential in 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.	Baseline, immediately after five brain stimulation sessions
9-hole pegboard test	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.	Baseline, immediately after five brain stimulation sessions
Grip & Tip pinch strength test	The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.	Baseline, immediately after five brain stimulation sessions
Box & Block test	The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.	Baseline, immediately after five brain stimulation sessions
Sequential Finger tapping test	Response time is measured during sequential finger tapping task.	Baseline, immediately after five brain stimulation sessions
Jebsen-Taylor hand function test	This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).	Baseline, immediately after five brain stimulation sessions

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting-state functional MRI	Before intervention, MRI is acquired to extract brain characteristics of stroke patients.	Baseline (Before stimulation sessions)
Changes in cortical activity using fNIRS signals.	Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.	Baseline (Before stimulation sessions)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 23, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021-04-075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No