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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Austria
Department for Neurology, Medical University of Innsbruck
RECRUITING
Innsbruck
Contact Information
Primary
Simon Sollereder, MSc
simon.sollereder@vascage.at
+43 664 1004838
Backup
Petr Simurda, MD
petr.simurda@vascage.at
+43 512 554 43513
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 10
Treatments
Experimental: All participants
25 BCI-FES therapy sessions over 13 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Medical University Innsbruck, g.tec medical engineering GmbH
Leads: VASCage GmbH

This content was sourced from clinicaltrials.gov