NCT07098572 Comparison of Four-Channel Functional Electrical Stimulation vs. One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients
| NCT ID | NCT07098572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH |
| Condition | Moderate Arm Paresis |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-07-14 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will compare two treatments that may help participants recover after having suffered from stroke. Persons who experience weakness or paralysis of their arms/hands will be randomly placed in one of two groups. Each receives treatment five times a week for three weeks. One group will be treated with electrostimulation following a cyclic pattern (control treatment), the other group will be treated with electrostimulation triggered by nerve signals (i.e. stimulation starts when they deliberately try to move their arm (investigational treatment). Before and after the three weeks and additionally 12 weeks later, the ability to move the arm and hand will be documented with standardized tests.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07098572 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Moderate Arm Paresis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07098572 currently recruiting?
Yes, NCT07098572 is actively recruiting participants. Contact the research team at studies@medel.com for enrollment information.
Where is the NCT07098572 trial being conducted?
This trial is being conducted at Hermagor, Austria, Zirl, Austria, Linz, Austria.
Who is sponsoring the NCT07098572 clinical trial?
NCT07098572 is sponsored by MED-EL Elektromedizinische Geräte GesmbH. The trial plans to enroll 44 participants.