BCI-assisted MI Intervention in Subacute Stroke

NACompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 28, 2021

Primary Completion Date

October 31, 2023

Study Completion Date

December 1, 2023

Conditions
StrokeMotor Disorders
Interventions
OTHER

EEG-based BCI system for (hand) Motor Imagery training

The Promotoer is an all-in-one BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback (EEG and EMG activity monitoring) and screen for the real-time ecological feedback to patient - a custom software program that provides a for (personalized) visual representation of the patient's own hands. As such, this software allows the therapists to create an artificial reproduction of a given patient's hand/forearm by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hand/forearm. Training consists of the MI tasks only of the affected hand, grasping or finger extension in separate runs. The trial length will include a constant baseline period of 4 sec and a task period of maximally 10 sec for BCI intervention group. Each training session will consist of 4 runs (20 trials each).

OTHER

Motor Imagery training

Training consists of MI tasks only of the affected hand, grasping or finger extension in separate runs. MI training will be delivered without BCI support (ie., the Promotoer system will not provide real-time feedback of MI performance; hand/forearm visual representation will remain standstill) with a dose/setting regimen equivalent to EXP intervention. The trial length will include a constant baseline period of 4 sec and a task period of maximally 4 sec. Each training session will consist of 4 runs (20 trials each).

Trial Locations (1)

00179

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS, Rome

All Listed Sponsors
collaborator

University of Roma La Sapienza

OTHER

collaborator

Istituto Superiore di Sanità

OTHER

lead

I.R.C.C.S. Fondazione Santa Lucia

OTHER

NCT04353297 - BCI-assisted MI Intervention in Subacute Stroke | Biotech Hunter | Biotech Hunter