Using brain-computer interface technology to help stroke patients regain upper limb function

Study of Functional Electrical Stimulation With Assistive Support Driven by a Brain-Computer Interface on the Upper Limb Rehabilitation of Chronic Stroke Patients

This study is testing whether a new brain-computer interface can help stroke patients regain use of their arms by improving their rehabilitation process.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Essex (other)
• Locations: 1 site (Vipiteno, South Tyrol)
• Trial ID: NCT06179745 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a brain-computer interface (BCI) combined with functional electrical stimulation (FES) and an active hand orthosis on upper limb rehabilitation in chronic stroke patients. The study is multi-center, randomized, sham-controlled, and double-blind, focusing on the functional recovery of the upper limb and the underlying neural plasticity mechanisms. Participants will be divided into a study group, where the BCI triggers the assistive devices based on detected motor intent, and a control group, where the devices are triggered randomly. The aim is to enhance the efficacy of rehabilitation therapies by restoring the connection between motor commands and sensory feedback.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have experienced a first stroke more than six months prior, resulting in severe paralysis of the upper limb.

Not a fit: Patients with conditions obstructing EEG acquisition or severe concomitant diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve upper limb function in chronic stroke patients, enhancing their quality of life.

How similar studies have performed: Previous studies using BCI technology for rehabilitation have shown promise, but this specific combination of interventions is relatively novel.

Eligibility criteria

Inclusion criteria:

* More than 18 years of age
* Victim of ischemic or haemorrhagic cerebrovascular accident (CVA)
* At least 6 months since occurrence of CVA. No upper limit on time since stroke is imposed
* First CVA
* Severe central paresis or complete paralysis of the upper limb, as quantified by a Medical Research Council (MRC) scale score ≤2 evaluated at the wrist and finger extension and flexion, and forearm flexion and extension Other concomitant motor disabilities do not constitute exclusion criteria.
* Unilateral cortical lesions (left or right hemisphere), subcortical lesions or supra-pontic lesions of the corticospinal tract having caused paralysis of the upper limb as documented by radiologic evidence
* Adequate or corrected vision

Exclusion criteria:

* Any reason obstructing EEG acquisition (scalp infections or wounds, dermatitis, etc)
* Severe concomitant diseases (fever, infections, cardiac conditions, etc)
* Heavy medication affecting the central nervous system (CNS, especially vigilance)
* CVA with multiple infarcts
* Second or later CVA
* Severe unilateral hemispatial neglect as assessed by the behavioural part of the Behavioural Inattention Test (BIT) and the Fluff Test for body neglect
* Severe cognitive disability affecting speech production, communication (e.g. aphasia), the ability to understand and give clear and free informed consent and to fully understand and comply with protocol instructions. A score of above 22/30 of the Montreal Cognitive Assessment (MoCA) scale is advised Inability to concentrate for 2 consecutive hours
* Concomitant neurological conditions (e.g. Parkinson's disease) Severe spasticity. The Modified Ashworth Scale (MAS) score at the elbow, wrist and fingers should be below or equal to 2.
* Severe dystonia, dyskinesia or pain
* Cardiac pacemaker, active implants and other contraindications for FES
* Metallic implants affecting EEG acquisition

Patients for whom it is not possible to evoke a MEP greater than or equal to 0.2 mV amplitude at rest from the FDI and more proximal muscles (like ECR, FDS, etc) of the affected limb, or with contraindications for the TMS or Diffusion Tensor Imaging (DTI) protocols, will not undergo the respective procedures but will not be excluded from the trial.

Where this trial is running

Vipiteno, South Tyrol

• Ospedale di Vipiteno | Azienda Sanitaria dell'Alto Adige — Vipiteno, South Tyrol, Italy (RECRUITING)

Study contacts

• Study coordinator: Serafeim Perdikis, PhD

Conditions: Stroke, Cerebrovascular, Hemiplegia and Hemiparesis, Stroke/Brain Attack