ClinicalTrials.gg
RecruitingNCT07098572MKES2Updated Aug 14, 2026

Comparison of Four-Channel Functional Electrical Stimulation vs. One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients

An interventional study of Cyclic single channel neuromuscular stimulation and Electromyogram-triggered 4 channel neuromuscular stimulation in Moderate Arm Paresis and Ischemic Stroke, sponsored by MED-EL Elektromedizinische Geräte GesmbH. Recruiting at 3 sites in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by MED-EL Elektromedizinische Geräte GesmbH · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Moderate Arm Paresis
  • Ischemic Stroke

Keywords

  • Arm Paresis
  • Hand Paresis
  • Stiwell Profes
  • Electrostimulation
  • Ischemic stroke
  • Rehabilitation
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 44 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH is the lead sponsor of 35 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Active comparator
    Cyclic Neuromuscular Electrical Stimulation (cNMES)

    Single channel cyclic neuromuscular stimulation used for the rehabilitation of moderate arm paresis

    Device: Cyclic single channel neuromuscular stimulation

  • Experimental
    Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES)

    EMG-triggered, four channel neuromuscular stimulation used for the rehabilitation of moderate arm paresis

    Device: Electromyogram-triggered 4 channel neuromuscular stimulation

Interventions

  • DeviceCyclic single channel neuromuscular stimulation

    Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions

  • DeviceElectromyogram-triggered 4 channel neuromuscular stimulation

    EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions

    Also known as: EMG-MES

06

What researchers measure

Primary outcomes

  1. Stroke Impact Scale (SIS) subscale Recovery

    Scores between 0 and 100, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

Secondary outcomes

  1. Stroke Impact Scale (SIS), subscale strength

    Scores between 0 and 100, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

  2. Stroke impact scale (SIS) subscale Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL)

    Scores between 0 and 100, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

  3. Stroke impact scale (SIS) subscale mobility

    Scores between 0 and 100, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

  4. Stroke impact scale (SIS) subscale hand function

    Scores between 0 and 100, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

  5. Fugl-Meyer Assessment - upper extremity (FMA-UE)

    Scores between 0 and 100, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

  6. Action Research Arm Test (ARAT)

    Scores between 0 and 57, higher meaning a better outcome

    Time frame: pre-intervention to 3 weeks

  7. Safety assessment

    Assessment of device related adverse events

    Time frame: through study completion, an average of 15 weeks

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Jan 2028, 29 months after the start.

Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 29 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2025
First posted
Aug 1, 2025
StartActual
Aug 12, 2025
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07098572
Responsible party
Sponsor
First posted
Aug 1, 2025
Start date
Aug 12, 2025
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 14, 2026

Study contacts

Florian Schwarze, PhD
Contact
studies@medel.com
+435 77 88

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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