BCI Post-stroke Neurorehabilitation

Poststroke/CVA Hemiparesis Clinical Trial

— BCI-stroke  

Official title:

A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404857
• Other study ID #: 9431
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: November 23, 2015
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hand Flaccid Paralysis
• Paralytic Stroke
• Poststroke/CVA Hemiparesis
• Stroke

Intervention

Device:
• EEG based Brain Computer Interface
Using EEG signals to classify brain activity being 'rest' or 'active' to control the attached pneumatic glove and close the sensory-motor loop between intentional/mental movement and physical (though passive) movement.

Locations

Country	Name	City	State
France	CHRU Lapeyronie	Montpellier	Herault

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Nimes, National University of Ireland, Maynooth, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the BCI-system (evaluation of performance through patient questionaires & the performance of the BCI classifier during intended and imagined hand movements)	Evaluation of the BCI-platform performance through patient questionnaires & 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).	No
Secondary	EEG sensory-motor rhythm signals (Detailed analysis of the EEG signals in relation to the severity of the paresis and movement condition)	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).	No