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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01470950
Other study ID # MMStudy
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 21, 2011
Last updated February 4, 2015
Start date May 2010
Est. completion date December 2015

Study information

Verified date February 2015
Source Clinique Romande de Readaptation
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethical Committee of Lucerne
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date December 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- acute, motor complete SCI

- lesion level C5-T12

Exclusion Criteria:

- diabetes type I

- pregnancy

- oral anti-coagulation

- osteosyntheses of the femur

- hepatitis B,C or D

- HIV

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Procedure:
Motionmaker
3 times per week, FES Training on the Motionmaker device, for 6 months

Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil Lucerne
Switzerland Clinique Romande de Réadaption Sion Valais

Sponsors (2)

Lead Sponsor Collaborator
Clinique Romande de Readaptation Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months No
Secondary Muscle strength Improvement of muscle strenght 6 months No
Secondary Spacity Reduction of spasticity 6 months No
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