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Brain-Computer device aims to restore swallowing and speech after stroke

NCT ID NCT06940635

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Recruiting now This study
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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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When the status isn't known

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study tests whether a brain-computer interface combined with electrical stimulation can improve swallowing difficulties and language problems in people who had a stroke at least three months ago. Ten participants will use the device for hand rehabilitation while researchers measure changes in swallowing and speech. The goal is to see if this approach can ease these common post-stroke symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Department for Neurology, Medical University of Innsbruck

    RECRUITING

    Innsbruck, Tyrol, 6020, Austria

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