Spinal Cord InjuryNCT02080039
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
A study testing Electrical Stimulation in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
In this study the following hypotheses will be tested: Electrical stimulation of the gluteal muscle (buttocks) leads to 1. an increase in the thickness of the gluteal muscle 2. a decrease in the thickness of the fat of the buttock area 3. 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?
- Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Nov 2014
- 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
- Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury
- Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)
Who cannot join
- Acute decubitus in the stimulated area
- Arteriosclerosis
- Less than three months after flap surgery or after decubitus in the stimulated area
- Infections or skin eczema in the stimulated area
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
In this study the following hypotheses will be tested:
Electrical stimulation of the gluteal muscle (buttocks) leads to
- an increase in the thickness of the gluteal muscle
- a decrease in the thickness of the fat of the buttock area
- a change in the distribution of the middle and maximal seating pressure to a more consistent pressure
- an increase in well-being of the patients.
- Conditions
- Spinal Cord Injury
- Being tested
- Electrical Stimulation
- Keywords
- Spinal Cord Injury, Denervation, Electrical Stimulation
- 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.
Electrical StimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation | Experimental | Not described Receives: Device: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
Measured: 45 min.
Secondary outcomes (2)
Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure
Measured: 15 min.
Questionnaire on subjective wellbeing
The subjective effect of the electric stimulation will be assessed by an 5-item-questionnaire. Since no standardised questionnaire is available to assess the well-being in relation to sitting in a wheelchair, an individual non-validated questionnaire has been developed. It contains five questions: Question 1 and 2 address the number of resting phases while lying down and the respective overall duration of decompression each day. The questions 3 to 5 focus on the fear of pressure sores while sitting, every day limitations based on decompression phases and the subjective well-being while sitting in a wheelchair. The subjects answer the questions using a visual analog scale of 10 cm, indicating 0=no fear/no impairment/no well-being; 10=high fear/high impairment/high well-being. The subjects complete the questionnaire at baseline (start of intervention), after three and after six months.
Measured: 10 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionNov 2014
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080039
- Sponsor's protocol ID
- 2012-13
- Status last verified
- Nov 2014
- First submitted
- 24 Feb 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study of the Effect of Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02080039
- Acronym / sponsor ID
- 2012-13
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Denervation, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Mar 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.
In this study the following hypotheses will be tested:
Electrical stimulation of the gluteal muscle (buttocks) leads to
- an increase in the thickness of the gluteal muscle
- a decrease in the thickness of the fat of the buttock area
- a change in the distribution of the middle and maximal seating pressure to a more consistent pressure
- an increase in well-being of the patients.
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: Electrical Stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury
- Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)
Key exclusion criteria (4 listed)
- Acute decubitus in the stimulated area
- Arteriosclerosis
- Less than three months after flap surgery or after decubitus in the stimulated area
- Infections or skin eczema in the stimulated area
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 |
|---|---|---|
| Electrical Stimulation | Device | Electrical Stimulation |
Primary outcome
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock.
Time frame: 45 min.
2 secondary outcomes
Measuring of the seating pressure to determine the distribution of the middle and maximal seating pressure
Time frame: 15 min.
Questionnaire on subjective wellbeing
Time frame: 10 min.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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 Electrical Stimulation 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 2 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: stopped early, as of the sponsor's last update on 20 Nov 2014. 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 was stopped early. Results are not available in the source record.
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?
Magnetic Resonance Imaging to determine the thickness of the gluteal muscle and fat tissue of the buttock. (time frame: 45 min.). 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 20 Nov 2014.