RecruitingNot Applicable

Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients

Austria10 participantsStarted 2025-06-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 treatmen…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Gugging Swallowing Screen (GUSS)

Timeframe: Baseline, treatment session 16, week 17, week 21 and week 47

Change in Bielefeld Aphasia Screening Reha (BIAS-R)

Timeframe: Baseline, treatment session 16, week 17, week 21 and week 47

Trial details

NCT IDNCT06940635

SponsorVASCage GmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Simon Sollereder, MSc

+43 664 1004838 simon.sollereder@vascage.at

View on ClinicalTrials.gov More Ischaemic Stroke trials