Tests a brain-controlled hand device for effects on swallowing and speech after stroke
Tests a brain-controlled stimulation device in adults with chronic stroke and swallowing or language problems.
Plain-language title generated from the registry record
Registry title: Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
Key facts
- Where
- Innsbruck, AustriaSee the site
Where in Austria
- Department for Neurology, Medical University of InnsbruckInnsbruck, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- VASCage GmbH
- Trial code
- NCT06940635
- Record updated
- 26 November 2025
- Original description
The goal of this neurorehabilitation explorative study is to investigate how a closed-loop Brain-Computer Interface Functional Electrical Stimulation (BCI-FES) therapy, used within the intended purpose for hand rehabilitation, may impact swallowing difficulties (dysphagia) and language disorders (aphasia) in post-stroke patients.Read full original descriptionShow less
Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study
The goal of this neurorehabilitation explorative study is to investigate how a closed-loop Brain-Computer Interface Functional Electrical Stimulation (BCI-FES) therapy, used within the intended purpose for hand rehabilitation, may impact swallowing difficulties (dysphagia) and language disorders (aphasia) in post-stroke patients.
Inclusion: 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: 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); 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; Stroke Location: Participants with a brainstem and/or cerebellar stroke; Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month; 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); Cognitive Impairments: Cognitive impairments that, in the investigator's judgment, could limit understanding of task instructions; Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension; 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; Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.