Brain Excitability and Connectivity in Sensory-motor Pathways in ALS (SOM_ALS)

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

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: structural MRI; Device: EEG/MEG; Device: functional MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03694132

C17-70

Details and patient eligibility

About

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).

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• contraindication to MRI

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

functional MRI

Experimental group

Description:

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

Treatment:

Device: functional MRI

structural MRI

Experimental group

Description:

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

Treatment:

Device: structural MRI

EEG/MEG

Experimental group

Description:

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

Treatment:

Device: EEG/MEG