Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis

NCT04868994 | Recruiting

• 1 other identifier: RC31/20/0217
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis With Dementia

Keywords

Amyotrophic; Sclerosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic certainty 1.ENMG according to El Escorial revised criteria using ENMG alone, MRI alone and ENMG+MRI to define denervation diffusion

  number of patients classified as possible, probable or certain according to El Escorial criteria using ENMG alone, IMR alone and ENMR+MRI

  1 month

Secondary Outcomes (1)

• Define precise topographic and characteristic of muscle involvement in ALS by MRI

  1 month

Study Arms (1)

ENMG and muscle analyses on whole body muscles MRI.

EXPERIMENTAL

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

Interventions

Whole Body MRI and ENMG DIAGNOSTIC_TEST

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

ENMG and muscle analyses on whole body muscles MRI.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Pascal CINTAS

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pascal CINTAS, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal CINTAS, MD PHD

CONTACT

05 61 77 94 40; cintas.p@chu-toulouse.fr

Anne Cecile Coville

CONTACT

(05345) 58700

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: May 3, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

FR (1)