Four-channel EMG-triggered vs single-channel cyclic electrical stimulation for moderate arm and hand weakness after stroke
Official title: Efficacy of EMG-triggered Four-Channel Functional Electrical Stimulation vs. Cyclic One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients. A Randomized Controlled Single Blinded Multicenter Study
Run by MED-EL Elektromedizinische Geräte GmbH · NCT07098572 · Data updated 2026-11-12
This will try to see if four-channel, EMG-triggered electrical stimulation helps people with moderate arm and hand weakness after ischemic stroke more than standard cyclic single-channel stimulation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | MED-EL Elektromedizinische Geräte GmbH Industry-sponsored |
| Locations | 3 sites (Hermagor, Carinthia and 2 other locations) |
| Status | Recruiting |
| Started | August 12, 2025 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07098572 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) with a first-time ischemic stroke in the early to late subacute phase (7 days–6 months) who have moderate arm paresis (Motricity Index UE sum 40–77) and were able to perform daily activities before the stroke.
✕Probably not a fit
Patients with severe contractures, implanted electronic devices (pacemakers, defibrillators, brain stimulators), active skin infections or wounds in the stimulation area, therapy-resistant epilepsy, unstable psychological status, pregnancy, or other listed exclusions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with a first-time ischemic stroke and moderate arm/hand paresis will be randomly assigned to receive either cyclic single-channel neuromuscular stimulation or electromyogram (EMG)-triggered four-channel stimulation. Treatments are given five times per week for three weeks, and motor function of the arm and hand is measured before treatment, immediately after the three-week course, and again 12 weeks later with standardized tests. The EMG-triggered approach initiates stimulation when the patient attempts voluntary movement, while the cyclic approach delivers preset stimulation cycles independent of patient effort. The trial is sponsored by MED-EL and carried out at three Austrian hospitals.
Why it matters
Potential benefit: If successful, the EMG-triggered four-channel approach could improve voluntary arm and hand movement recovery beyond what cyclic single-channel stimulation provides.
How similar studies have gone: Previous studies of EMG-triggered and multi-channel functional electrical stimulation have shown promising but mixed results, so this approach has supportive but not definitive evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * First-time ischemic stroke with moderate arm paresis (Motricity Index - UE Sum-Score ≥ 40 ≤ 77 points) (Collin \& Wade, 1990) * Early to late subacute phase (7 days - 6 months) (Bernhardt et al., 2017) * Existing ADL ability before the event (ICF d5 self-care, d6 domestic life, extent of problem ≤1 points) (WHO, 2001) * Age ≥18 - 99 years * Signed and dated ICF before the start of any study-specific procedure. Exclusion Criteria: * Lack of compliance with any inclusion criteria * Implanted defibrillators, brain stimulators, pacemakers, medication pumps * Therapy-resistant epilepsy * Fever or infectious diseases * Inflammatory or tumorous skin diseases in the stimulation area, * Thromboses or vein inflammations * Severe contractures of the affected extremity * Wounds in the stimulation area * Pregnancy * Known allergic reactions to components of the investigational medical device * Unstable psychological status * Participation in other pharmacological clinical investigations within four weeks prior to enrolment * Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Where it's running
-
KABEG Gailtal-Klinik LKH Hermagor
Hermagor, Carinthia, Austria Recruiting -
Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl
Zirl, Tyrol, Austria Recruiting -
Kepler Universitätsklinikum Linz
Linz, Upper Austria, Austria Recruiting
Study contacts
- Study coordinator: Florian Schwarze, PhD
- Email: studies@medel.com
- Phone: +435 77 88
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.