Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma. (CAMIK)
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional brain MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Anterior Cruciate Ligament Rupture focused on measuring arthrogenic muscle inhibition, anterior cruciate ligament, functional brain MRI, Central nervous system, Knee trauma
Eligibility Criteria
Inclusion Criteria:
- male patient, right-handed,
- aged between 20 and 30,
- 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).
Sites / Locations
- Pierre Paul Riquet HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
with arthrogenic Muscle Inhibition
without arthrogenic Muscle Inhibition
Arm Description
Outcomes
Primary Outcome Measures
Matrix of correlation coefficients
A matrix of correlation coefficients, measured by MRI, representing the strength of the sensory-motor network connectivity at rest for each group.
Secondary Outcome Measures
Activation map of the motor representations of knee movement
An activation map of the motor representations of knee movement are measured by MRI
Full Information
NCT ID
NCT03950024
First Posted
May 9, 2019
Last Updated
January 2, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03950024
Brief Title
Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma.
Acronym
CAMIK
Official Title
Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Arthrogenic Muscle Inhibition (AMI) is one of the classic complications occurring in the aftermath of knee trauma; AMI is grossly defined as a lack of extension due to quadriceps inhibition and hamstring contracture. However, its origins remains unknown with a strong suspicion for a central brain origin. It could be the missing link explaining this lack of extension following an anterior cruciate ligament (ACL) rupture. The primary hypothesis of this study is that a difference in activation of motor brain areas exists in patients with an ACL rupture, between those with AMI or without. The second hypothesis is that this difference could be seen on brain functional MRI.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
arthrogenic muscle inhibition, anterior cruciate ligament, functional brain MRI, Central nervous system, Knee trauma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, monocentric, interventional, comparative, controlled, non-randomized study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with arthrogenic Muscle Inhibition
Arm Type
Experimental
Arm Title
without arthrogenic Muscle Inhibition
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
functional brain MRI
Intervention Description
The functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task. (knee bent)
Primary Outcome Measure Information:
Title
Matrix of correlation coefficients
Description
A matrix of correlation coefficients, measured by MRI, representing the strength of the sensory-motor network connectivity at rest for each group.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Activation map of the motor representations of knee movement
Description
An activation map of the motor representations of knee movement are measured by MRI
Time Frame
Day 0
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Etienne CAVAIGNAC, MD
Phone
+33 5 61 77 55 81
Ext
+33
Email
cavaignac.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne CAVAIGNAC, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pierre Paul Riquet Hospital
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ETIENNE CAVAIGNAC, MI
Phone
+33 5 61 77 55 81
Ext
+33
Email
cavaignac.e@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
CHARLINE DAGUZAN
Phone
+33 5 61 77 84 90
Ext
+33
Email
daguzan.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
ETIENNE CAVAIGNAC, MI
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma.
We'll reach out to this number within 24 hrs