An interventional study of closed-loop BCI-FES device in Ischaemic Stroke and Hemorrhagic Stroke, sponsored by VASCage GmbH. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by VASCage GmbH · Not applicable, Interventional, and Treatment
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.
Stroke is the leading cause of permanent disability worldwide. Neurorehabilitation (i.e. physical, occupational, and speech/swallowing therapy) is essential for neurological recovery after stroke. According to principles of neuroplasticity and motor learning, key elements are high-intensity training paradigms with task repetition, therapy feedback and cueing modalities. Technical equipment can assist therapists in reaching these aims, for example by facilitating self-training.
One significant technological advancement in this therapeutic field is Brain-Computer Interface (BCI). BCI most commonly uses EEG-signals (i.e. electroencephalography) to capture task related electrical brain activities related to Motor Imagery (MI) translating it for "closed" neurofeedback. Moreover, BCI is frequently coupled with Functional Electrical Stimulation (FES), which stimulates physical movement in the paretic limb while the MI-related tasks are executed. The processed signals are translated into commands to control an external device. The combination of BCI-feedback technology and FES is primarily used to ensure concurrent sensory feedback with motor intention of a goal-based task to restore sensory-motor functions. In the current approach electrical activity related to the MI of upper limb movements is captured and transferred to a corresponding avatar on a computer screen as feedback for the patient.
c-STEPS is designed as a open-label, single-centre, non-controlled, prospective explorative interventional pre-post study. The primary objective of this study is to explore changes in dysphagia or aphasia in stroke patients with arm paresis treated with a closed-loop BCI-FES therapy (used within the intended purpose for hand rehabilitation). Further study objectives are to assess the impact of established treatment protocols on overall independence, disease severity and quality of life related to dysphagia and aphasia, and to investigate simultaneous recovery patterns in hand motor function, dysphagia, and aphasia using a BCI-FES system.
c-STEPS will enroll 10 participants (+2 potential replacements) who are in the chronic post-stroke phase (≥3 months after an ischemic or haemorrhagic stroke). Participants must present with residual arm paresis and either dysphagia (MUCCS-N ≥2) and/or aphasia (AAT ≤3).
Key exclusion criteria include cognitive impairments affecting compliance, brainstem/cerebellar strokes, previous disabling stroke, uncontrolled epilepsy, pacemakers or implanted devices incompatible with FES, severe neglect or anosognosia, and ongoing botulinum toxin treatment. Participants with severe cardiovascular or respiratory conditions (NYHA IV, COPD IV) or other medical risks affecting safety will also be excluded.
The participants will undergo 25 BCI-FES therapy sessions over 13 weeks (twice a week, 45-minute sessions). Throughout the intervention period, interim assessments will be conducted at predefined time points to evaluate treatment progress. A post-treatment assessment will be performed one week after the final therapy session, with additional follow-up assessments at 4 weeks and 26 weeks post-treatment. The overall study duration per participant is 48 weeks.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 10 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →VASCage GmbH is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Speech/Swallowing Impairment: Participants must have:
Exclusion Criteria:
Co-morbidities: The following conditions will exclude participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
25 BCI-FES therapy sessions over 13 weeks
Device: closed-loop BCI-FES device
Closed-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.
Time frame: Baseline, treatment session 16, week 17, week 21 and week 47
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.
Time frame: Baseline, treatment session 16, week 17, week 21 and week 47
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.
Time frame: Baseline, week 17, week 21 and week 47
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).
Time frame: Baseline, week 17, week 21 and week 47
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.
Time frame: Baseline, week 17, week 21 and week 47
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.
Time frame: Baseline, week 17, week 21 and week 47
Change in Nine-Hole Peg Test (NHPT)
The NHPT measures fine motor skills and dexterity of the upper extremity, particularly focusing on hand function. Performance-based timed test; outcome = time in seconds required to complete the task.
Time frame: Baseline, treatment sessions 6, 16 and 21, week 17, week 21 and week 47
Change in Box-and-Block Test (BBT)
The BBT is a standardised test used to evaluate gross manual dexterity. It assesses the patient's ability to grasp, lift, and transfer blocks from one side of a box to another. Performance-based test; outcome = number of blocks transferred in 60 seconds.
Time frame: Baseline, week 17, week 21 and week 47
Change in Scores of Independence for Neurologic and Geriatric Rehabilitation (SINGER)
The SINGER measures independence in daily activities and is specifically designed for neurological and geriatric rehabilitation settings. Ordinal scale; higher scores reflect greater independence in daily activities during neurorehabilitation.
Time frame: Baseline, week 17, week 21 and week 47
Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
The EQ-5D-3L is a widely used instrument to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level ordinal scale. The EQ-5D-3L also contains a visual analogue scale (VAS) from 0 to 100.
Time frame: Baseline, week 17, week 21 and week 47
Change in Scale for Measuring Digital Technology Acceptance Adapted for Digital Therapeutic Devices (DTAS-th)
The DTAS-th is an adapted instrument originally designed to assess the acceptance of new technologies. The DTAS-th emphasizes two key dimensions: perceived usefulness, which refers to the therapists' view of how effective the treatment method is in improving patient outcomes, and perceived ease of use, which captures how user-friendly and practical the method is from the therapists' perspective. 13-item questionnaire based on the Technology Acceptance Model (TAM). Each item is rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
Time frame: Treatment Sessions 6 and 21, week 17
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