BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke

Summary

Multi-center, randomized, sham-controlled, double-blind, longitudinal, experimental clinical study to investigate functional recovery effects on the upper limb in chronic stroke patients and the accompanying neural plasticity mechanisms after the application of a brain-computer interface (BCI)-driven functional electrical stimulation (FES) therapy supported by an assistive device (hand orthosis). All the equipment used during the study will be applied in compliance with the indications and methods of use for which it is authorized. Therefore, the results will not extend the indications for the use of the equipment and will not explicitly target industrial development. The study is non-profit and is aimed at improving clinical practice. The study involves two clinical centers. The promoting center is the Vipiteno Neurorehabilitation Department, Italy. The aggregate experimentation center is the Neurology Department of Hochzirl Hospital, Austria. The University of Essex, United Kingdom is the technology provider and data analysis center.

Conditions

• Stroke, Cerebrovascular
• Hemiplegia and Hemiparesis
• Stroke/Brain Attack

Interventions

COMBINATION_PRODUCT

EEG-based brain-computer interface

EEG-based brain-computer interface detecting the patient's EEG sensorimotor rhythms associated to attempted reach-gasp-release upper limb movements by the patient.

COMBINATION_PRODUCT

Sham EEG-based brain-computer interface

Fake (Sham) EEG-based brain-computer interface which outputs a decision at random about whether EEG sensorimotor rhythms associated to attempted reach-gasp-release upper limb movements by the patient are currently detected.

DEVICE

Functional Electrical Stimulation

Neuromuscular stimulation of several upper limb muscles (elbow extensors, hand extensors/flexors) to effectuate reach, grasp and release movements of the affected upper limb.

DEVICE

Active hand orthosis

Active hand orthosis effectuating reach, grasp and release movements of the affected uppe r limb.

Sponsors & Collaborators

• Azienda Sanitaria dell'Alto Adige

  collaborator OTHER

• Landeskrankenhaus Hochzirl

  collaborator UNKNOWN

• University of Essex

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-14

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Italy

Study Locations