Spinal Cord InjuryNCT02265042
Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury
A study testing Stimulette in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Stimulette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic spinal cord injury (min. 2 years after injury)
- lesion height from T10-L5
- ASIA (American Spinal Cord Injury Association) Impairment Scale A
Who cannot join
- acute pressure sore in stimulated area (M. gluteus)
- arteriosclerosis
- skin irritation or infection in stimulated area (M. gluteus)
- < 3 months after plastic surgery in stimulated area (M. gluteus)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.
- Conditions
- Spinal Cord Injury
- Being tested
- Stimulette
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimuletteDevice
electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation | Experimental | electrical Stimulation using the Stimulette device Receives: Device: Stimulette |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in muscle volume
determination of muscle volume using magnetic resonance images
Measured: day 0 to 3 months
Secondary outcomes (5)
change in muscle volume
determination of muscle volume using magnetic resonance images
Measured: 3 months to 6 months
change in sitting pressure
pressure mapping system
Measured: day 0 to 3 months
change in sitting pressure
pressure mapping system
Measured: 3 months to 6 months
change in quality of life
questionnaire
Measured: day 0 to 3months
change in quality of life
questionnaire
Measured: 3 months to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 2012
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Bersch-Porada Ines, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265042
- Sponsor's protocol ID
- 2012-13
- Status last verified
- Nov 2025
- First submitted
- 7 Oct 2014
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02265042
- Acronym / sponsor ID
- 2012-13
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Jan 2012 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation | Experimental | Device: Stimuletteelectrical Stimulation using the Stimulette device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic spinal cord injury (min. 2 years after injury)
- lesion height from T10-L5
- ASIA (American Spinal Cord Injury Association) Impairment Scale A
Key exclusion criteria (4 listed)
- acute pressure sore in stimulated area (M. gluteus)
- arteriosclerosis
- skin irritation or infection in stimulated area (M. gluteus)
- < 3 months after plastic surgery in stimulated area (M. gluteus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimuletteelectrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria | Device | electrical stimulation |
Primary outcome
change in muscle volume
Time frame: day 0 to 3 months
determination of muscle volume using magnetic resonance images
5 secondary outcomes
change in muscle volume
Time frame: 3 months to 6 months
change in sitting pressure
Time frame: day 0 to 3 months
change in sitting pressure
Time frame: 3 months to 6 months
change in quality of life
Time frame: day 0 to 3months
change in quality of life
Time frame: 3 months to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulette in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in muscle volume (time frame: day 0 to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.