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New treatment option for Ischaemic Stroke
Official title Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
ClinicalTrials.gov ID: NCT06940635
What this study is testing
- What it's testing
- 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.
- Time commitment: about 13 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Tyrol, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 13 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Tyrol, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.