Actively Recruiting
Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study
Led by VASCage GmbH · Updated on 2025-11-26
10
Participants Needed
1
Research Sites
N/A
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
Researchers are exploring how a closed-loop Brain-Computer Interface Functional Electrical Stimulation (BCI-FES) therapy, designed for hand rehabilitation, might also affect swallowing difficulties (dysphagia) and language disorders (aphasia) in patients who have experienced a stroke at least three months ago. This study focuses on patients with residual arm weakness following ischemic or hemorrhagic stroke and aims to understand the potential cross-system recovery effects using this innovative neurorehabilitation approach. The trial is an open-label, single-center, non-controlled, prospective exploratory intervention study.
CONDITIONS
Brief 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...
- Age 18 years or older
- At least 3 months after ischemic or hemorrhagic stroke
- Disabling left or right arm weakness (arm motor drift score of 1 or more)
- Aphasia score of 3 or less and/or dysphagia score of 2 or more
- Stable neurological status with no relevant changes in past 4 weeks
- Ability to lift at least one block in a hand coordination test
- Ability to understand basic spoken instructions
- Ability to sit for at least 60 minutes
- Willing and able to give informed consent
You will not qualify if you...
- Cognitive impairments limiting understanding of instructions
- Brainstem or cerebellar stroke
- Previous disabling stroke
- Severe hemi-neglect or anosognosia limiting treatment compliance
- Severe spasticity causing complete limb rigidity
- Uncontrolled epilepsy or seizure in last month
- Ongoing elevated intracranial pressure
- Implanted devices incompatible with electrical stimulation like pacemakers
- Metallic fragments in the limb planned for stimulation
- Unhealed fractures or skin/tissue lesions in the stimulated limb
- Joint stiffness or contraction limiting treatment in the wrist
- Botulinum toxin treatment within 6 weeks or planned during study
- Chronic obstructive pulmonary disease stage IV
- Cardiac insufficiency NYHA stage IV
- Severe acute infections
- Significant circulatory or sensory disorders in stimulated limb
- Other medical conditions limiting safety or study performance
- Known intolerance to electrical stimulation on the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 13 weeks
Participants undergo 25 BCI-FES therapy sessions over 13 weeks, with each session lasting approximately 45 minutes. This therapy combines brain-computer interface technology with functional electrical stimulation to support motor recovery.
Twice weekly visits for 25 sessions
Duration - Up to 35 weeks
Participants attend post-treatment assessments to evaluate progress and recovery in dysphagia, aphasia, and motor function.
3 visits at 1 week, 4 weeks, and 26 weeks after therapy completion
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
P
Petr Simurda, MD
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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