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Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis (MIDALS)

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ClinicalTrials.gov Identifier: NCT04868994
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
Nearly 60% of Amyotrophic Lateral Sclerosis (ALS) patients have a low level of diagnostic certainty (possible, probable) at the time of diagnosis. In the absence of biomarkers, this diagnosis is based, among other things, on the demonstration of the diffusion of signs of denervation by electroneuromyography (ENMG). The objective of this study is to improve the earliness and the level of diagnostic certainty by better demonstrating the diffusion of the denervation process by whole body muscular MRI.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis With Dementia Diagnostic Test: Whole Body MRI and ENMG Not Applicable

Detailed Description:
The objective of this study is to show that the combination of ENMG and whole body muscle MRI (WB-MRI) can increase the diagnosis of definite ALS at the onset of the disease For 50 consecutive patients with suspected ALS, the present study will prospectively perform needle electromyography (EMG) and muscle analyses on whole body MRI. The diagnostic category will be determined by revised El Escorial criteria and Awaji criteria. On whole body MRI acquisition, for 83 muscles, will be explored fatty infiltration and atrophy on fat images (chronic denervation) and muscle edema on water images (acute denervation). EMG studies will be performed in at least 10 muscles (tongue, biceps brachii, first dorsalis interosseous, T10 paraspinalis, vastus lateralis, and tibialis anterior). Diagnostic classification according EMG and/ or MRI abnormalities in bulbar and the 3 spinal regions will be compared independently.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ENMG and muscle analyses on whole body muscles MRI.
Diffusion of active and chronic muscle denervation will be assessed on ENMG and whole body muscle MRI. The diagnostic category will be determined by revised El Escorial criteria and Awaji criteria
 Diagnostic Test: Whole Body MRI and ENMG
Whole body muscle MRI lasting 30 to 45 min without injection of contrast medium an ENMG


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic certainty 1.ENMG according to El Escorial revised criteria using ENMG alone, MRI alone and ENMG+MRI to define denervation diffusion [ Time Frame: 1 month ]
    number of patients classified as possible, probable or certain according to El Escorial criteria using ENMG alone, IMR alone and ENMR+MRI


Secondary Outcome Measures :
  1. Define precise topographic and characteristic of muscle involvement in ALS by MRI [ Time Frame: 1 month ]
    number of patients with concordance between ENMG and MRI for the detection of denervation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consent form signed by the patient
  • Patients suspected ALS defined according Awaji Shima criteria (possible, probable, defined)
  • Clinical assessment of upper motor neuron involvement
  • Electrophysiologic assessment of lower motor neuron involvement

Exclusion Criteria:

  • inability to give informed consent
  • a contraindication to MRI
  • respiratory failure impairing ability to lie flat in the scanner.
  • Patient placed under judicial protection or under another protective regime,
  • Females who are pregnant
Contacts and Locations
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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): NCT04868994


Contacts
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Contact: Pascal CINTAS, MD PHD 05 61 77 94 40 cintas.p@chu-toulouse.fr
Contact: Anne Cecile Coville (05345) 58700

Locations
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France
Pascal CINTAS Recruiting
Toulouse, France, 31000
Contact: Pascal CINTAS, MD PHD    0561779440    cintas.p@chu-toulouse.fr   
Contact: Anne Cecile Coville    0534558700      
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Pascal CINTAS, MD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04868994    
Other Study ID Numbers: RC31/20/0217
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022

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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:
Amyotrophic
Sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases