Ischaemic Strokec-STEPSNCT06940635
Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
A study testing closed-loop BCI-FES device in people with Ischaemic Stroke and Hemorrhagic Stroke, run by VASCage GmbH at 1 site in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Stroke, Hemorrhagic Stroke
- What is being tested?
- closed-loop BCI-FES device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 4 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department for Neurology, Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Michael Knoflach, Assoc.-Prof., +43 512 504 81697, michael.knoflach@i-med.ac.at
Michael Knoflach, Assoc.-Prof.
About this study
Official title: Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Ischaemic Stroke, Hemorrhagic Stroke
- Being tested
- closed-loop BCI-FES device
- Keywords
- neurorehabilitation, BCI-FES, chronic stroke, aphasia, dysphagia
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Aphasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop BCI-FES deviceDevice
Closed-loop neurorehabilitation system that combines EEG-based brain-computer interface technology with functional electrical stimulation (FES) to facilitate neural and motor recovery.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | 25 BCI-FES therapy sessions over 13 weeks Receives: Device: closed-loop BCI-FES device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, treatment session 16, week 17, week 21 and week 47
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Treatment Sessions 6 and 21, week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start4 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VASCage GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- g.tec medical engineering GmbH, Medical University Innsbruck
- Responsible party
- Sponsor
- Investigators
- Michael Knoflach, Assoc.-Prof., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940635
- Sponsor's protocol ID
- C_2_BC.4.2_0046_010
- Acronym
- c-STEPS
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06940635
- Acronym / sponsor ID
- c-STEPS / C_2_BC.4.2_0046_010
- Conditions
- Ischaemic Stroke, Hemorrhagic Stroke
- Keywords
- neurorehabilitation, BCI-FES, chronic stroke, aphasia, dysphagia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- VASCage GmbHUniversity, hospital or other
- Collaborators
- g.tec medical engineering GmbH, Medical University Innsbruck
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: closed-loop BCI-FES device25 BCI-FES therapy sessions over 13 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Stable Neurological Status: No relevant changes in neurological status in the past 4 weeks (self-reported).
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed-loop BCI-FES deviceClosed-loop neurorehabilitation system that combines EEG-based brain-computer interface technology with functional electrical stimulation (FES) to facilitate neural and motor recovery. | Device | All participants |
Primary outcome
Change in Gugging Swallowing Screen (GUSS)
Time frame: Baseline, treatment session 16, week 17, week 21 and week 47
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)
Time frame: Baseline, treatment session 16, week 17, week 21 and week 47
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.
9 secondary outcomes
Change in Munich Swallowing Score (MUCCS)
Time frame: Baseline, week 17, week 21 and week 47
Change in M.D. Anderson Dysphagia Inventory (M.D.ADI)
Time frame: Baseline, week 17, week 21 and week 47
Change in Communication Outcome after Stroke (COAST)
Time frame: Baseline, week 17, week 21 and week 47
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline, week 17, week 21 and week 47
Change in Nine-Hole Peg Test (NHPT)
Time frame: Baseline, treatment sessions 6, 16 and 21, week 17, week 21 and week 47
Change in Box-and-Block Test (BBT)
Time frame: Baseline, week 17, week 21 and week 47
Change in Scores of Independence for Neurologic and Geriatric Rehabilitation (SINGER)
Time frame: Baseline, week 17, week 21 and week 47
Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
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)
Time frame: Treatment Sessions 6 and 21, week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Ischaemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Knoflach, Assoc.-Prof. principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed-loop BCI-FES device in people with Ischaemic Stroke and Hemorrhagic Stroke, run by VASCage GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Sollereder, MSc (+43 664 1004838, simon.sollereder@vascage.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gugging Swallowing Screen (GUSS) (time frame: Baseline, treatment session 16, week 17, week 21 and week 47). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.