The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

NCT ID: NCT05142917

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2023-01-08

Brief Summary

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The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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fNIRS based hand motor area real stimulation

Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Hand motor task

Intervention Type BEHAVIORAL

Various type of hand motor tasks are applied to stroke patients.

Traditional hand motor area real stimulation

Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Hand motor task

Intervention Type BEHAVIORAL

Various type of hand motor tasks are applied to stroke patients.

Traditional hand motor area sham stimulation

Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).

Group Type SHAM_COMPARATOR

Hand motor task

Intervention Type BEHAVIORAL

Various type of hand motor tasks are applied to stroke patients.

Interventions

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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.

Intervention Type DEVICE

Hand motor task

Various type of hand motor tasks are applied to stroke patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Unilateral stroke patients aged 19 to 80 years
* Patients with subacute stroke within 4 weeks of onset
* Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation

Exclusion Criteria

* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
* If there are difficulties in conducting the research
* Any patients who are judged by the investigator to be difficult to participate in this study

i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2021-10-092-001

Identifier Type: -

Identifier Source: org_study_id

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