Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

National Rehabilitation Center, Seoul, Korea

Status: Unknown

Conditions: Stroke

Treatments: Device: Experimental: RecoveriX with individual EEG calibration; Device: RecoveriX without individual EEG calibration

Study type: Interventional

Funder types: Other

Identifiers

NCT04451941

NRC-2020-01-007

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

RecoveriX with individual EEG calibration

Experimental group

Description:

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

Treatment:

Device: Experimental: RecoveriX with individual EEG calibration

RecoveriX without individual EEG calibration

Sham Comparator group

Description:

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

Treatment:

Device: RecoveriX without individual EEG calibration