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出境医 / 临床实验 / Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma. (CAMIK)
Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma. (CAMIK)
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.
| 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.
Study Design
| 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. |
| Actual Study Start Date : | October 29, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Eligibility Criteria
| 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).
Contacts and Locations
Contacts
| Contact: Etienne CAVAIGNAC, MD | +33 5 61 77 55 81 ext +33 | cavaignac.e@chu-toulouse.fr |
Locations
| France | |
| Pierre Paul Riquet Hospital | 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
| Principal Investigator: | Etienne CAVAIGNAC, MD | University Hospital, Toulouse |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 9, 2019 | ||||
| First Posted Date ICMJE | May 14, 2019 | ||||
| Last Update Posted Date | August 26, 2020 | ||||
| Actual Study Start Date ICMJE | October 29, 2019 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improvement of Knowledge About the Arthrogenic Muscle Inhibition in the Aftermath of Knee Trauma. | ||||
| Official Title ICMJE | Contribution of Functional Brain MRI to the Understanding of Arthrogenic Muscle Inhibition (AMI) in the Aftermath of Knee Trauma. | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Anterior Cruciate Ligament Rupture | ||||
| Intervention ICMJE | 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)
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 2021 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 30 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03950024 | ||||
| Other Study ID Numbers ICMJE | RC31/19/0029 2019-A00479-48 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University Hospital, Toulouse | ||||
| Study Sponsor ICMJE | University Hospital, Toulouse | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Toulouse | ||||
| Verification Date | August 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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