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

NCT06940635 | Recruiting

• 1 other identifier: C_2_BC.4.2_0046_010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 post-stroke patients.

Conditions

Ischaemic Stroke; Hemorrhagic Stroke

Keywords

neurorehabilitation; BCI-FES; chronic stroke; aphasia; dysphagia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, treatment session 16, week 17, week 21 and week 47

Secondary Outcomes (9)

• Change in Munich Swallowing Score (MUCCS)

  Baseline, week 17, week 21 and week 47

• Change in M.D. Anderson Dysphagia Inventory (M.D.ADI)

  Baseline, week 17, week 21 and week 47

• Change in Communication Outcome after Stroke (COAST)

  Baseline, week 17, week 21 and week 47

• Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Baseline, week 17, week 21 and week 47

• Change in Nine-Hole Peg Test (NHPT)

  Baseline, treatment sessions 6, 16 and 21, week 17, week 21 and week 47

Study Arms (1)

All participants

EXPERIMENTAL

25 BCI-FES therapy sessions over 13 weeks

Device: closed-loop BCI-FES device

Interventions

closed-loop BCI-FES device DEVICE

Closed-loop neurorehabilitation system that combines EEG-based brain-computer interface technology with functional electrical stimulation (FES) to facilitate neural and motor recovery.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Co-morbidities: The following conditions will exclude participation:
• Chronic Obstructive Pulmonary Disease (Stage IV).
• Cardiac insufficiency (NYHA Stage IV).

Sponsors & Collaborators

• VASCage GmbH: lead
• g.tec medical engineering GmbH: collaborator
• Medical University Innsbruck: collaborator

Study Sites (1)

Department for Neurology, Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Aphasia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Michael Knoflach, Assoc.-Prof.

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Sollereder, MSc

CONTACT

+43 664 1004838; simon.sollereder@vascage.at

Petr Simurda, MD

CONTACT

+43 512 554 43513; petr.simurda@vascage.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 23, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)