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Trial record 9 of 306 for:    Recruiting, Not yet recruiting, Available Studies | Inhibition

Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma. (CAMIK)

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ClinicalTrials.gov Identifier: NCT03950024
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Diagnostic Test: functional brain MRI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, monocentric, interventional, comparative, controlled, non-randomized study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma.
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: with arthrogenic Muscle Inhibition Diagnostic Test: functional brain MRI
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 Diagnostic Test: functional brain MRI
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950024


Contacts
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Contact: Etienne CAVAIGNAC, MD +33 5 61 77 55 81 ext +33 cavaignac.e@chu-toulouse.fr

Locations
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France
Pierre Paul Riquet Hospital Not yet recruiting
Toulouse, Occitanie, France, 31300
Contact: ETIENNE CAVAIGNAC, MI    +33 5 61 77 55 81 ext +33    cavaignac.e@chu-toulouse.fr   
Contact: CHARLINE DAGUZAN    +33 5 61 77 84 90 ext +33    daguzan.c@chu-toulouse.fr   
Principal Investigator: ETIENNE CAVAIGNAC, MI         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Etienne CAVAIGNAC, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03950024     History of Changes
Other Study ID Numbers: RC31/19/0029
2019-A00479-48 ( Other Identifier: ANSM )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
arthrogenic muscle inhibition
anterior cruciate ligament
functional brain MRI
Central nervous system
Knee trauma
Additional relevant MeSH terms:
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Rupture
Knee Injuries
Wounds and Injuries
Leg Injuries