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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVASCage GmbH

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

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

VASCage GmbH

Lead sponsor

g.tec medical engineering GmbH

Collaborator

Medical University Innsbruck

Collaborator