๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ1).
* Speech/Swallowing Impairment: Participants must have:
* Aphasia (AAT-Skala zum Kommunikationsverhalten score โค3), and/or
* Dysphagia (MUCCS-N score โฅ2).
* 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.