Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

NCT04451941 | Unknown

• 1 other identifier: NRC-2020-01-007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

brain machine interface; chronic stroke; wrist extensor strength

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - upper extremity

  Fugl-Meyer Assessment is indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment. Total scores range from 0 to 66, each item being scored on a 3-point scale (0, cannot perform; 1, partially performs; and 2, fully performs the task).

  4 weeks after baseline

Secondary Outcomes (13)

• Box and block test

  baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

• Jebsen hand function test

  baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

• 9-hole peg test

  baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

• Medical Research Council (MRC) scale of affected upper extremity

  baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

• Joint position sense

  baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

Study Arms (2)

RecoveriX with individual EEG calibration

EXPERIMENTAL

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

Device: Experimental: RecoveriX with individual EEG calibration

RecoveriX without individual EEG calibration

SHAM COMPARATOR

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

Device: RecoveriX without individual EEG calibration

Interventions

Experimental: RecoveriX with individual EEG calibration DEVICE

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

RecoveriX with individual EEG calibration

RecoveriX without individual EEG calibration DEVICE

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

RecoveriX without individual EEG calibration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Rehabilitation Center, Seoul, Korea: lead

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joon-Ho Shin

  National Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin

CONTACT

82-2-901-1884; asfreelyas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Brain Injury Rehabilitation Department, Principal Investigator

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 30, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

KR (1)