Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Device: structural MRI; Device: EEG/MEG; Device: functional MRI

• Registration Number: NCT03694132
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Study Start: 2018-11-26
• Primary Completion: 2019-12-31
• Study Completion: 2021-03-31
• Status Verified: 2021-09
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

• contraindication to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
structural MRI	structural MRI	a group of patients with ALS and a group of gender and age matched healthy subjects will have diffusion MRI acquisition to evaluate their brain structures
EEG/MEG	EEG/MEG	a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical stimuli of ADM proprioceptors
functional MRI	functional MRI	a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical and mechanical stimuli of ADM proprioceptors

Primary Outcome Measures

Name	Time	Method
Brain activity	1 hour	Brain parametric maps

Secondary Outcome Measures

Name	Time	Method
Brain connectivity	15 min	diffusion brain MRI (tractography)

Trial Locations

Locations (1)

Hopital Pitie-Salpetriere; 🇫🇷 Paris, France