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NCT Number: NCT04868994

Magnetic Imaging for Diagnostic of Amyotrophic Lateral Sclerosis

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Body MRI and ENMG

Diagnostic Test

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

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

    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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Cecile Coville

CONTACT

(05345) 58700

Pascal CINTAS, MD PHD

CONTACT

[email protected]

05 61 77 94 40

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.

Acronym: MIDALS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 3, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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