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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Motor learning
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Real stimulation before motor learning training

Sham stimulation before motor learning training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in cortical activity using fNIRS signals during brain stimulation
Cortical activities before, during and after brain stimulation sessions are compared.
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.
9-hole pegboard test
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Grip & Tip pinch strength test
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
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.
Sequential Finger tapping test
Response time is measured during sequential finger tapping task.
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).

Full Information

First Posted
May 23, 2021
Last Updated
February 27, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04903457
Brief Title
The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients
Official Title
Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
June 14, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real stimulation before motor learning training
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham stimulation before motor learning training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
Intervention Type
Behavioral
Intervention Name(s)
Motor learning
Intervention Description
Sequential finger tapping task training is applied to stroke patients.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Time Frame
Baseline, immediately after five brain stimulation sessions
Secondary Outcome Measure Information:
Title
Changes in cortical activity using fNIRS signals during brain stimulation
Description
Cortical activities before, during and after brain stimulation sessions are compared.
Time Frame
Baseline, during, immediately after five brain stimulation sessions
Title
Changes in motor evoked potential
Description
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.
Time Frame
Baseline, immediately after five brain stimulation sessions
Title
9-hole pegboard test
Description
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Time Frame
Baseline, immediately after five brain stimulation sessions
Title
Grip & Tip pinch strength test
Description
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Time Frame
Baseline, immediately after five brain stimulation sessions
Title
Box & Block test
Description
The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
Time Frame
Baseline, immediately after five brain stimulation sessions
Title
Sequential Finger tapping test
Description
Response time is measured during sequential finger tapping task.
Time Frame
Baseline, immediately after five brain stimulation sessions
Title
Jebsen-Taylor hand function test
Description
This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
Time Frame
Baseline, immediately after five brain stimulation sessions
Other Pre-specified Outcome Measures:
Title
Resting-state functional MRI
Description
Before intervention, MRI is acquired to extract brain characteristics of stroke patients.
Time Frame
Baseline (Before stimulation sessions)
Title
Changes in cortical activity using fNIRS signals.
Description
Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.
Time Frame
Baseline (Before stimulation sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

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

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