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.
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).
Aphasia (AAT-Skala zum Kommunikationsverhalten score ≤3), and/or
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).
Single group
closed-loop BCI-FES device
DeviceClosed-loop neurorehabilitation system that combines EEG-based brain-computer interface technology with functional electrical stimulation (FES) to facilitate neural and motor recovery.
Change in Gugging Swallowing Screen (GUSS)
The GUSS is a standardised assessment tool used to evaluate swallowing ability and the risk of aspiration in patients with dysphagia. 4-step clinical assessment; total score ranges from 0 to 20 points. It includes an initial screening followed by assessments of different consistencies of food and drink to determine swallowing safety.
Change in Bielefeld Aphasia Screening Reha (BIAS-R)
The BIAS-R is a validated, and standardised assessment tool specifically designed to assess language impairments in aphasic patients in the post-acute stage. It evaluates different aspects of language function such as comprehension, expression, and overall communication ability for different linguistic domains. It is a score-based aphasia screening tool; total score indicates severity of language impairment.
Change in Munich Swallowing Score (MUCCS)
The MUCCS assesses swallowing function by rating specific criteria related to oral and pharyngeal swallowing phases on two subscales related to saliva swallow (MUCCS-S and oral intake (MUCCS-N). It is a 16-point Likert scale clinical rating.
Change in M.D. Anderson Dysphagia Inventory (M.D.ADI)
The M.D.ADI evaluates the impact of dysphagia on a patient's quality of life. 20-item, 5-point Likert scale per item. Provides subscale scores (emotional, functional, physical) and a total composite score. Composite Score ranges from 20 (extremely low functioning) to 100 (high functioning).
Change in Communication Outcome after Stroke (COAST)
The COAST measures the impact of stroke on communication abilities and social participation, focusing on how well individuals are able to interact in everyday situations. The primary caregiver of the study participant will complete this outcome assessment. 2 domains, each item rated on a 5-point Likert scale.
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
The FMA-UE is a stroke-specific assessment used to evaluate motor recovery in the upper extremity, focusing on range of motion, coordination, and reflexes. Ordinal 3-point scale per item (0-2); maximum score: 66.
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VASCage GmbH
Lead sponsor
g.tec medical engineering GmbH
Collaborator
Medical University Innsbruck
Collaborator
