Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 7:07 PM
Study NCT ID:
NCT06940635
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study on the Potential Cross-System Effects of BCI-FES Hand Therapy on Dysphagia and Aphasia in Chronic Stroke Patients
Sponsor:
VASCage GmbH
Organization:
Study Overview
Official Title:
Cross-Stroke Therapy Effects With BCI and FES Stimulation: A Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
c-STEPS
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: