BCI Post-stroke Neurorehabilitation

Not Applicable

Completed

• Conditions: Hand Flaccid Paralysis; Paralytic Stroke; Poststroke/CVA Hemiparesis
• Interventions: Device: EEG based Brain Computer Interface

• Registration Number: NCT02404857
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.

Detailed Description

Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-04-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• > 6 months post-stroke (chronic), unilateral
• > 18 yrs
• little to no hand movement
• spasticity < 3 on modified Ashworth Scale

Exclusion Criteria

• major cognitive deficits (Folstein mini mental status > 23
• strong hemi-neglect (Catherine Bergego scale > 15/30)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic post-stroke	EEG based Brain Computer Interface	Patients \>6 months post-stroke with little to no hand movement. use of EEG based BCI in the neurorehabilitation process

Primary Outcome Measures

Name	Time	Method
Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)	During the whole study. Assesment is made for each patient after his participation ( 2 hours).	Evaluation of the BCI-platform performance through patient questionnaires \& the performance of the BCI classifier during intended and imagined hand movements.

Secondary Outcome Measures

Name	Time	Method
EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)	During the whole studyAssesment is made for each patient after his participation ( 2 hours).	Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition

Trial Locations

Locations (1)

CHRU Lapeyronie; 🇫🇷 Montpellier, Herault, France