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A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Transcranial direct current simulation

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
Subcortical stroke
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 with metal implants
History of epilepsy
Pregnancy
Skin defect at the site of electrode attachment

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS stimulation group

Arm Description

Patients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system.

Outcomes

Primary Outcome Measures

Changes in cortical activity using fNIRS signals during brain stimulation

Cortical activities before and after brain stimulation sessions are compared.

Secondary Outcome Measures

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.

Fugl-Meyer Assessment

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

Finger tapping test

Response time is measured during finger tapping task.

Full Information

NCT ID

NCT04549753

First Posted

September 2, 2020

Last Updated

March 8, 2021

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04549753

Brief Title

A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

Official Title

A Study on Brain Activity During Transcranial Direct Current Stimulation for Improving Finger-Hand Function in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

September 15, 2020 (Actual)

Primary Completion Date

December 10, 2020 (Actual)

Study Completion Date

December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS stimulation group

Arm Type

Experimental

Arm Description

Patients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current simulation

Intervention Description

Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system

Primary Outcome Measure Information:

Title

Changes in cortical activity using fNIRS signals during brain stimulation

Description

Cortical activities before and after brain stimulation sessions are compared.

Time Frame