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

Prior treatment

• 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).
• 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.

Other illness

• Stroke Location: Participants with a brainstem and/or cerebellar stroke.
• Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month.
• 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).

Other

• Cognitive Impairments: Cognitive impairments that, in the investigator's judgment, could limit understanding of task instructions.
• Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension.
• 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.
• Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.

• 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.