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

Recruiting now · Not applicable

Conditions studied: Ischaemic Stroke, Hemorrhagic Stroke

In brief

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.

Key facts

Study ID

NCT06940635

Run by

VASCage GmbH

People needed

10

Starts

2025-06-04

Expected to finish

2026-06-30

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Anosognosia: Pronounced anosognosia at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
• Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension.
• Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month.
• Intracranial Pressure: Known ongoing elevated intracranial pressure.
• Implanted Medical Devices: Participants with implanted medical devices with contraindication for FES such as pacemakers.
• Metallic Fragments: Participants with implanted metallic fragments in the extremity planned for FES that would limit the use of functional electrical stimulation (FES).
• Unhealed Injuries: Unrecovered fractures or skin/tissue lesions in the FES stimulated extremity.
• Joint Issues: Ossification, contraction, or stiffness of the wrist joint in the FES stimulated extremity that would limit treatment.
• Botulinum Toxin: Participants who received botulinum-toxin treatment within 6 weeks prior to study inclusion and/or for whom botulinum-toxin treatment is planned during the study duration.
• Co-morbidities: The following conditions will exclude participation:
• Chronic Obstructive Pulmonary Disease (Stage IV).
• Cardiac insufficiency (NYHA Stage IV).
• Severe acute infections.
• Significant circulatory disturbances in the stimulated extremity.
• Sensory disorders that significantly impair the patient's ability to feel pain or react to unsuitable proprioceptive stimuli.
• Any other general medical conditions that, in the investigator's judgment, limit the safety or performance of study procedures (investigator's judgement).
• Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.

Where it is running

• Department for Neurology, Medical University of Innsbruck — Innsbruck, Tyrol, Austria (enrolling)

Full record on ClinicalTrials.gov

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