Actively Recruiting
Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
Led by VASCage GmbH · Updated on 2025-11-26
10
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
V
VASCage GmbH
Lead Sponsor
G
g.tec medical engineering GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Participants must be in the chronic post-stroke phase (more than 3 months after ischemic or haemorrhagic stroke).
- Participants must have disabling residual arm weakness (arm motor drift score of 1 or higher).
- Participants must have aphasia (AAT score 3 or lower) and/or dysphagia (MUCCS-N score 2 or higher).
- Participants must have stable neurological status without relevant changes in the past 4 weeks.
- Participants must be able to raise at least one block similar to those in the Box-and-Block-Test.
- Participants must understand basic spoken instructions.
- Participants must be able to sit for at least 60 minutes.
- Participants must be willing and able to give informed consent.
You will not qualify if you...
- Participants with cognitive impairments that limit understanding of task instructions.
- Participants with brainstem or cerebellar stroke.
- Participants with a previous disabling stroke.
- Participants with pronounced hemi-neglect limiting treatment compliance.
- Participants with pronounced anosognosia limiting treatment compliance.
- Participants with severe spasticity causing complete rigidity in the affected limb.
- Participants with uncontrolled epilepsy or seizure within the last month.
- Participants with ongoing elevated intracranial pressure.
- Participants with implanted devices contraindicated for FES such as pacemakers.
- Participants with metallic fragments in the limb planned for FES.
- Participants with unrecovered fractures or skin/tissue injuries in the FES limb.
- Participants with ossification, contraction, or stiffness of the wrist joint limiting treatment.
- Participants who received botulinum toxin treatment within 6 weeks before inclusion or plan to receive it during the study.
- Participants with severe chronic obstructive pulmonary disease (stage IV).
- Participants with severe heart failure (NYHA stage IV).
- Participants with severe acute infections.
- Participants with major circulatory disturbances in the stimulated limb.
- Participants with sensory disorders impairing pain or proprioceptive responses.
- Participants with any other medical conditions limiting safety or study procedures.
- Participants who cannot tolerate electrical skin stimulation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department for Neurology, Medical University of Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
Research Team
S
Simon Sollereder, MSc
CONTACT
P
Petr Simurda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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