Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis

NCT ID: NCT04868994

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Amyotrophic Lateral Sclerosis With Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Whole Body MRI and ENMG

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Whole Body MRI and ENMG

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal CINTAS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Pascal CINTAS

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pascal CINTAS, MD PHD

Role: CONTACT

cintas.p@chu-toulouse.fr

05 61 77 94 40

Anne Cecile Coville

Role: CONTACT

(05345) 58700

Facility Contacts

Pascal CINTAS, MD PHD

Role: primary

cintas.p@chu-toulouse.fr

0561779440

Anne Cecile Coville

Role: backup

0534558700

Other Identifiers

RC31/20/0217

Identifier Type: -

Identifier Source: org_study_id