About this trial
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.
Eligibility criteria
Qualifiers
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).
Aphasia (AAT-Skala zum Kommunikationsverhalten score ≤3), and/or
Disqualifiers
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).
Trial design
Treatments tested in this trial
- closed-loop BCI-FES device
Treatment groups
Sponsors and collaborators
VASCage GmbH
Lead sponsor
g.tec medical engineering GmbH
Collaborator
Medical University Innsbruck
Collaborator