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

March 8, 2021 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS stimulation group
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.
Device: Transcranial direct current simulation
Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cortical activity using fNIRS signals during brain stimulation
Time Frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Cortical activities before and after brain stimulation sessions are compared.
Baseline and about 10 days (immediately after brain stimulation sessions)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in motor evoked potential
Time Frame: Baseline and about 10 days (immediately after brain stimulation sessions)
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 and about 10 days (immediately after brain stimulation sessions)
9-hole pegboard test
Time Frame: Baseline and about 10 days (immediately after brain stimulation sessions)
The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Baseline and about 10 days (immediately after brain stimulation sessions)
Grip & Tip pinch strength test
Time Frame: Baseline and about 10 days (immediately after brain stimulation sessions)
The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Baseline and about 10 days (immediately after brain stimulation sessions)
Box & Block test
Time Frame: Baseline and about 10 days (immediately after 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.
Baseline and about 10 days (immediately after brain stimulation sessions)
Fugl-Meyer Assessment
Time Frame: Baseline and about 10 days (immediately after brain stimulation sessions)
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Baseline and about 10 days (immediately after brain stimulation sessions)
Finger tapping test
Time Frame: Baseline and about 10 days (immediately after brain stimulation sessions)
Response time is measured during finger tapping task.
Baseline and about 10 days (immediately after brain stimulation sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 10, 2020

Study Completion (Actual)

December 10, 2020

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-04-183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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