Spinal Cord InjuriesNCT01470950
Characterization of the Changes in the Signalling Pathways During Spinal Cord Injury-induced Skeletal Muscle Atrophy
A study testing Motionmaker in people with Spinal Cord Injuries and Muscle Atrophy, run by Clinique Romande de Readaptation at 2 sites in Switzerland.
Trial summary
Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR pathways are involved in muscle hypertrophy in mice. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries, Muscle Atrophy
- What is being tested?
- Motionmaker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSwitzerland
- Study dates
- May 2010to Dec 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute, motor complete SCI
- lesion level C5-T12
Who cannot join
- diabetes type I
- pregnancy
- oral anti-coagulation
- osteosyntheses of the femur
- hepatitis B,C or D
- HIV
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
Clinique Romande de Réadaption
Sion, Valais, 1951
About this study
Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR pathways are involved in muscle hypertrophy in mice. Recent studies by the investigators team and others have demonstrated the implication of these signalling pathways in the control of muscle mass in humans. However no study has yet investigated the involvement of these systems in the early stages of spinal cord injury induced human skeletal muscle atrophy.
The investigators propose to investigate the level of expression of the different components of the ubiquitin-proteasome system together with the level of expression and activity of the Akt/mTOR and Akt/GSK3 signalling pathways after SCI in humans during the first months following the injury.
Read more
A second aim of this project is to assess if a novel apparatus of electrical stimulation which generate movements by closed-loop electrical muscle stimulation may improve strength and muscle mass in these patients.
The patients will be recruited jointly at the Clinique Romande de Réadaptation (CRR) in Sion and the Swiss paraplegic centre in Nottwil. They will be randomly divided into two groups, a first group of patients will undergo a conventional treatment of rehabilitation while a second set of patients will be treated using a brand new system of electro-stimulation called MotionMaker TM. Biopsies will be obtained in the first weeks after admission; two other biopsies will be taken respectively 3 and 6 months post-lesion.
Our results will provide an increased understanding of the molecular mechanisms contributing to skeletal muscle atrophy during the early stages following SCI and a characterization of the impact of endurance training in the no more voluntary innervated muscle. Moreover this study will also investigate the potential improvement in the rehabilitation process by using a new system of electro-stimulation.
Read the detailed description
Measures:
For each group, the muscle biopsies will be divided into 3 samples which will be used for a) real-time PCR to quantify the gene expression of the different components of the ubiquitin-proteasome system (Atrogin-1, MuRF1, Nedd4, UBB and Psma) b) Western blotting, using anti-phospho-site specific antibodies to quantify the activities of the Akt/GSK3 and Akt/mTOR pathways and of their downstream regulators of protein synthesis, eIF2B, p70S6K and PHAS-1/4E-BP1and c) fiber type analysis to quantify the variation in MHC expression.
- Conditions
- Spinal Cord Injuries, Muscle Atrophy
- Being tested
- Motionmaker
- Keywords
- Functional Electrical Stimulation, Signalling Pathways
- Medical subject headings
- Spinal Cord Injuries, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MotionmakerProcedure or surgery
3 times per week, FES Training on the Motionmaker device, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| MotionMaker Training | Experimental | Device description: MotionMaker™ is a stationary robotic system for the active mobilization of the lower limbs. With its proprietary 'Closed-Loop' technology, it is a novel and exciting development that offers a truly interactive patient training system Training 3 times a week with MotionMaker device together with conventional treatment Receives: Procedure: Motionmaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signaling pathways in human muscles after spinal cord injury
Molecular adaptations will be assessed from biopsies of the Vastus Lateralis muscle. Quantitative PCR method will allow to measure mRNA expression levels while proteins quantification will be performed by Western Blot analyses.
Measured: 6 months
Secondary outcomes (2)
Muscle strength
Improvement of muscle strenght
Measured: 6 months
Spacity
Reduction of spasticity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Responsible party
- Principal investigator, Bertrand LEGER, Clinique Romande de Readaptation
- Investigators
- Bertrand Léger, PhD, Principal investigator, CRR SionMichael E Baumberger, MD, Principal investigator, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470950
- Sponsor's protocol ID
- MMStudy
- Status last verified
- Feb 2015
- First submitted
- 21 Sep 2011
- Last updated
- 5 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Changes in the Signalling Pathways During Spinal Cord Injury-induced Skeletal Muscle Atrophy
- ClinicalTrials.gov ID
- NCT01470950
- Acronym / sponsor ID
- MMStudy
- Conditions
- Spinal Cord Injuries, Muscle Atrophy
- Keywords
- Functional Electrical Stimulation, Signalling Pathways
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Nov 2011 (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.
Atrogin-1 and muscle RING finger-1 are skeletal muscle specific genes, with ubiquitin ligase activities, that are upregulated during muscle atrophy in mice. The Akt/GSK3 and Akt/mTOR pathways are involved in muscle hypertrophy in mice. Recent studies by the investigators team and others have demonstrated the implication of these signalling pathways in the control of muscle mass in humans. However no study has yet investigated the involvement of these systems in the early stages of spinal cord injury induced human skeletal muscle atrophy.
The investigators propose to investigate the level of expression of the different components of the ubiquitin-proteasome system together with the level of expression and activity of the Akt/mTOR and Akt/GSK3 signalling pathways after SCI in humans during the first months following the injury.
A second aim of this project is to assess if a novel apparatus of electrical stimulation which generate movements by closed-loop electrical muscle stimulation may improve strength and muscle mass in these patients.
The patients will be recruited jointly at the Clinique Romande de Réadaptation (CRR) in Sion and the Swiss paraplegic centre in Nottwil. They will be randomly divided into two groups, a first group of patients will undergo a conventional treatment of rehabilitation while a second set of patients will be treated using a brand new system of electro-stimulation called MotionMaker TM. Biopsies will be obtained in the first weeks after admission; two other biopsies will be taken respectively 3 and 6 months post-lesion.
Our results will provide an increased understanding of the molecular mechanisms contributing to skeletal muscle atrophy during the early stages following SCI and a characterization of the impact of endurance training in the no more voluntary innervated muscle. Moreover this study will also investigate the potential improvement in the rehabilitation process by using a new system of electro-stimulation.
Detailed description
Measures:
For each group, the muscle biopsies will be divided into 3 samples which will be used for a) real-time PCR to quantify the gene expression of the different components of the ubiquitin-proteasome system (Atrogin-1, MuRF1, Nedd4, UBB and Psma) b) Western blotting, using anti-phospho-site specific antibodies to quantify the activities of the Akt/GSK3 and Akt/mTOR pathways and of their downstream regulators of protein synthesis, eIF2B, p70S6K and PHAS-1/4E-BP1and c) fiber type analysis to quantify the variation in MHC expression.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MotionMaker Training | Experimental | Procedure: MotionmakerDevice description: MotionMaker™ is a stationary robotic system for the active mobilization of the lower limbs. With its proprietary 'Closed-Loop' technology, it is a novel and exciting development that offers a truly interactive patient training system Training 3 times a week with MotionMaker device together with conventional treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- acute, motor complete SCI
- lesion level C5-T12
Key exclusion criteria (6 listed)
- diabetes type I
- pregnancy
- oral anti-coagulation
- osteosyntheses of the femur
- hepatitis B,C or D
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 |
|---|---|---|
| Motionmaker3 times per week, FES Training on the Motionmaker device, for 6 months | Procedure or surgery | MotionMaker Training |
Primary outcome
Signaling pathways in human muscles after spinal cord injury
Time frame: 6 months
Molecular adaptations will be assessed from biopsies of the Vastus Lateralis muscle. Quantitative PCR method will allow to measure mRNA expression levels while proteins quantification will be performed by Western Blot analyses.
2 secondary outcomes
Muscle strength
Time frame: 6 months
Spacity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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.
Bertrand Léger, PhD principal investigator
CRR Sion
Michael E Baumberger, MD principal investigator
Swiss Paraplegic Research, Nottwil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motionmaker in people with Spinal Cord Injuries and Muscle Atrophy, run by Clinique Romande de Readaptation at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Signaling pathways in human muscles after spinal cord injury (time frame: 6 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 5 Feb 2015.