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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
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 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Individualized stimulation group

Conventional stimulation group

Sham stimulation group

Arm Description

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.

Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.

Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.

Outcomes

Primary Outcome Measures

Changes in motor evoked potential
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

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).
9-hole peg 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.
Fugl-Meyer Assessment
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Sequential motor test
Response time and accuracy are measured during finger tapping task.

Full Information

First Posted
January 5, 2021
Last Updated
February 1, 2023
Sponsor
Samsung Medical Center
Collaborators
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04699331
Brief Title
Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
Official Title
Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Pusan National University Yangsan Hospital

4. Oversight

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

5. Study Description

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.

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
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized stimulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional stimulation group
Arm Type
Active Comparator
Arm Description
Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.
Arm Title
Sham stimulation group
Arm Type
Sham Comparator
Arm Description
Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.
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.
Primary Outcome Measure Information:
Title
Changes in motor evoked potential
Description
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.
Time Frame
Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Secondary Outcome Measure Information:
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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Title
9-hole peg test
Description
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Time Frame
Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (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, 1 day (immediately after one brain stimulation session) and about 14 days (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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Title
Sequential motor test
Description
Response time and accuracy are measured during finger tapping task.
Time Frame
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)

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

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