Skip to main content
OpenTrials
Completed

NCT Number: NCT03694132

Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

The main objective is to determine the origin of somatosensory alteration in patients with ALS and to evaluate its impact on brain activity by coupling different imaging modalities and indirect electrophysiology.

The secondary objective is to evaluate whether the observed functional changes in MEG / EEG and functional MRI correlate with structural lesions revealed with diffusion MRI (anatomo-functional connectivity of the brain).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Pitie-Salpetriere

Paris, 75013, France

About this study

Somatosensory evoked potentials (SEPs) produced by ulnar nerve electrical stimulation will be collected with combined MEG and EGG.

Functional MRI will be performed during electrical stimulation of ulnar nerve and during mechanical vibration of ADM tendon.

Brain diffusion MRI will be performed. Anatomical MRI will be done for source location. Brain resting state activity will be recorded with MEG/EEG and fMRI.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ALS, MRC score ≥ 4 at least in one hand
  • Controls: no history of neurological disorders, right-handed

Exclusion criteria

  • contraindication to MRI

Treatment and study plan

Functional MRI

Device

conditioning brain activity with peripheral stimulations

structural MRI

Device

diffusion MRI and tractography for evaluating the brain structures

EEG/MEG

Device

conditioning brain activity with peripheral stimulations

Primary outcomes

  1. Brain activity

    Time frame: 1 hour

    Brain parametric maps

Secondary outcomes

  1. Brain connectivity

    Time frame: 15 min

    diffusion brain MRI (tractography)

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology

Acronym: SOM_ALS

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Oct 3, 2018
Registry last updated
Nov 18, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.