Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

NCT ID: NCT04451941

Last Updated: 2020-07-31

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-12-31

Brief Summary

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Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength

Detailed Description

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The purpose of this study is to compare RecoveriX with individual EEG calibration and without individual EEG calibration to determine the clinical effect of brain machine interface in chronic stroke patient without wrist extensor strength

Conditions

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Stroke

Keywords

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brain machine interface chronic stroke wrist extensor strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RecoveriX with individual EEG calibration

RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks

Group Type EXPERIMENTAL

Experimental: RecoveriX with individual EEG calibration

Intervention Type DEVICE

RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks

RecoveriX without individual EEG calibration

RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks

Group Type SHAM_COMPARATOR

RecoveriX without individual EEG calibration

Intervention Type DEVICE

RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks

Interventions

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Experimental: RecoveriX with individual EEG calibration

RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks

Intervention Type DEVICE

RecoveriX without individual EEG calibration

RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hemiplegic patients secondary to first cerebrovascular accidents
* Weak wrist extension
* Onset ≥ 6 months
* Fugl-Meyer Assessment score ≥ 19
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria

* Wrist extensor spasticity above or modified ashworth scale 2
* Severe upper extremity pain that could interfere with rehabilitation therapy
* Neurological disorders other than stroke that can cause motor deficits
* Uncontrolled severe medical conditions.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Joon-Ho Shin

Chief of Brain Injury Rehabilitation Department, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon-Ho Shin

Role: PRINCIPAL_INVESTIGATOR

National Rehabilitation Center

Locations

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National Rehabilitation Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joon-Ho Shin

Role: CONTACT

Phone: 82-2-901-1884

Email: [email protected]

Facility Contacts

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Joon-Ho Shin, MS

Role: primary

Other Identifiers

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NRC-2020-01-007

Identifier Type: -

Identifier Source: org_study_id