Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis (MIDALS)

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

Tracking Information

• First Submitted Date: March 26, 2021
• First Posted Date: May 3, 2021
• Last Update Posted Date: July 29, 2022
• Actual Study Start Date: June 1, 2021
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2021)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 27, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis
• Official Title: Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Amyotrophic Lateral Sclerosis With Dementia

Intervention

Diagnostic Test: Whole Body MRI and ENMG

Whole body muscle MRI lasting 30 to 45 min without injection of contrast medium an ENMG

Study Arms

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

Intervention: Diagnostic Test: Whole Body MRI and ENMG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 27, 2021): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pascal CINTAS, MD PHD; 05 61 77 94 40; cintas.p@chu-toulouse.fr

Contact: Anne Cecile Coville; (05345) 58700

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04868994
• Other Study ID Numbers: RC31/20/0217
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Toulouse
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Toulouse
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pascal CINTAS, MD; University Hospital, Toulouse

• PRS Account: University Hospital, Toulouse
• Verification Date: July 2022