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

NCT ID: NCT04699331

Last Updated: 2023-02-03

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-12-23

Brief Summary

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This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Individualized stimulation group

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.

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.

Conventional stimulation group

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

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.

Sham stimulation group

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

Group Type SHAM_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.

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

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yun-Hee Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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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2019-07-107

Identifier Type: -

Identifier Source: org_study_id

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