- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03950024
Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma. (CAMIK)
Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AMI leads to quadriceps atrophy, persistent knee pain, dynamic instability, and a higher rate of osteoarthritis. A recent literature review suggests that the AMI phenomenon is multifactorial, but not widely known and poorly understood. Known mechanisms include impaired motor function at rest, impaired transmission of information from joint sensory receptors, impaired excitability of the spinal reflex and impaired cortical activity. Several studies have suggested a link between ACL rupture and central nervous system reorganization. Among the neurophysiological investigations explored are the evoked somesthesic potentials, electroencephalography, and transcranial magnetic stimulation (TMS). However, these mechanisms alone do not explain the phenomenon in its entirety, suggesting that there are other mechanisms. Furthermore, no study has used functional brain MRI to assess the existence of similar changes in AMI.
This study plans to compare two groups of patients with an ACL rupture: a group with AMI, and a group without AMI. Both groups will undergo a functional brain MRI in order to analyse any modification of the sensory-motor network connectivity that could occur.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Occitanie
-
Toulouse, Occitanie, France, 31300
- Pierre Paul Riquet Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- male patient, right-handed,
- with a severe right knee sprain in the event of ACL rupture,
- occurrence of trauma within 4 weeks prior to inclusion,
- with a score of ≥ 8/10 on the Edinburgh Manual Laterality Questionnaire, -affiliated or benefiting from public health services.
Exclusion Criteria:
- person presenting any of these conditions : professional player / athlete, -contraindication to the MRI examination (claustrophobic patient, patient with a metallic element),
- patient already operated on with ligament damage to the knee other than ACL,
- patient with iterative ACL rupture,
- patient who has undergone contralateral ligament reconstruction,
- patient with multi-ligamentary knee injury,
- patient refusing to be informed of any abnormality detected on brain MRI, -protected patient (adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: with arthrogenic Muscle Inhibition
|
The functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task.
(knee bent)
|
|
Active Comparator: without arthrogenic Muscle Inhibition
|
The functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task.
(knee bent)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Matrix of correlation coefficients
Time Frame: Day 0
|
A matrix of correlation coefficients, measured by MRI, representing the strength of the sensory-motor network connectivity at rest for each group.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activation map of the motor representations of knee movement
Time Frame: Day 0
|
An activation map of the motor representations of knee movement are measured by MRI
|
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Etienne CAVAIGNAC, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/19/0029
- 2019-A00479-48 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.