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

Exclusion Criteria21

• 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.