tDCS Response Prediction Using EEG in Stroke

NCT ID: NCT04830631

Last Updated: 2022-05-17

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-03-31

Brief Summary

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Patients with chronic stroke (\>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.

Detailed Description

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Conditions

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Stroke Rehabilitation Transcranial Direct Current Stimulation Motor Recovery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex

Cathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age ranges from 19 to 85 yrs old
* stroke patients with unilateral hemiparesis
* 1st ever stroke
* chronic stroke (\>6 months after stroke)

Exclusion Criteria

* recurrent stroke
* history of traumatic brain injury
* Minimental state examination score is 15 or less.
* Unstable medical conditions
* Severe delirium, disorders of consciousness
* pregnancy
* can not attach tDCS electrode on the scalp due to skin conditions
* can not maintain the sitting position
* intracranial metals
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rusk Rehabilitation Hospital

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won-Seok Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Rusk Rehabilitation Hospital

Seongnam-si, Please Select, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Won-Seok Kim

Role: CONTACT

+82317877735

Facility Contacts

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Won-Seok Kim

Role: primary

0317877735

Chaiyoung Lim, MD

Role: primary

Other Identifiers

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B-2004/608-004

Identifier Type: -

Identifier Source: org_study_id

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