Exploring the effects of BCI-FES hand therapy on swallowing and speech in stroke patients

Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study

This study is testing whether a new therapy using brain signals and electrical stimulation can help stroke patients improve their swallowing and speech abilities.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VASCage GmbH (other)
• Locations: 1 site (Innsbruck, Tyrol)
• Trial ID: NCT06940635 on ClinicalTrials.gov

What this trial studies

This exploratory study investigates the impact of a closed-loop Brain-Computer Interface Functional Electrical Stimulation (BCI-FES) therapy on dysphagia and aphasia in chronic stroke patients. The therapy aims to enhance neurorehabilitation by utilizing EEG signals to provide feedback during motor imagery tasks, which may improve both hand function and communication abilities. Participants will engage in high-intensity training with the BCI-FES device, designed to stimulate movement and provide sensory feedback. The study is open-label and conducted at a single center, focusing on the potential cross-system effects of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are in the chronic phase post-stroke with motor and speech/swallowing impairments.

Not a fit: Patients who are not in the chronic phase post-stroke or do not exhibit significant motor or speech/swallowing impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve swallowing and speech abilities in chronic stroke patients.

How similar studies have performed: While the combination of BCI and FES is a novel approach, similar studies have shown promise in enhancing motor function in stroke rehabilitation.

Eligibility criteria

Inclusion Criteria:

* Age: Participants must be aged 18 years or older.
* Post-Stroke Phase: Participants must be within the chronic post-stroke phase (time since ischemic or haemorrhagic stroke greater than 3 months).
* Motor Impairment: Participants must exhibit disabling left or right residual arm paresis ("left/right arm motor drift" part of the NIHSS score ≥1).
* Speech/Swallowing Impairment: Participants must have:

  * Aphasia (AAT-Skala zum Kommunikationsverhalten score ≤3), and/or
  * Dysphagia (MUCCS-N score ≥2).
* Stable Neurological Status: No relevant changes in neurological status in the past 4 weeks (self-reported).
* Motor Function: Participants must be able to raise at least 1 block similar to the ones in Box-and-Block-Test.
* Cognitive Understanding: Participants must be able to understand basic spoken instructions.
* Sitting Tolerance: Participants must be able to maintain a sitting position for at least 60 minutes.
* Willingness to Participate: Participants must be willing to participate in the study and able to understand and sign the informed consent.

Exclusion Criteria:

* Cognitive Impairments: Cognitive impairments that, in the investigator's judgment, could limit understanding of task instructions.
* Stroke Location: Participants with a brainstem and/or cerebellar stroke.
* Previous Stroke: Participants with a previous disabling stroke.
* Hemi-Neglect: Pronounced hemi-neglect at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
* Anosognosia: Pronounced anosognosia at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
* Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension.
* Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month.
* Intracranial Pressure: Known ongoing elevated intracranial pressure.
* Implanted Medical Devices: Participants with implanted medical devices with contraindication for FES such as pacemakers.
* Metallic Fragments: Participants with implanted metallic fragments in the extremity planned for FES that would limit the use of functional electrical stimulation (FES).
* Unhealed Injuries: Unrecovered fractures or skin/tissue lesions in the FES stimulated extremity.
* Joint Issues: Ossification, contraction, or stiffness of the wrist joint in the FES stimulated extremity that would limit treatment.
* Botulinum Toxin: Participants who received botulinum-toxin treatment within 6 weeks prior to study inclusion and/or for whom botulinum-toxin treatment is planned during the study duration.
* Co-morbidities: The following conditions will exclude participation:

  * Chronic Obstructive Pulmonary Disease (Stage IV).
  * Cardiac insufficiency (NYHA Stage IV).
  * Severe acute infections.
  * Significant circulatory disturbances in the stimulated extremity.
  * Sensory disorders that significantly impair the patient's ability to feel pain or react to unsuitable proprioceptive stimuli.
  * Any other general medical conditions that, in the investigator's judgment, limit the safety or performance of study procedures (investigator's judgement).
* Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.

Where this trial is running

Innsbruck, Tyrol

• Department for Neurology, Medical University of Innsbruck — Innsbruck, Tyrol, Austria (RECRUITING)

Study contacts

• Principal investigator: Michael Knoflach, Assoc.-Prof. — Medical University Innsbruck
• Study coordinator: Simon Sollereder, MSc

Conditions: Ischaemic Stroke, Hemorrhagic Stroke, neurorehabilitation, BCI-FES, chronic stroke, aphasia, dysphagia