Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 6, 2018

Estimated Primary Completion Date

November 6, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Brain activity[ Time Frame: 1 hour ]

Brain parametric maps

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Brain connectivity[ Time Frame: 15 min ]
diffusion brain MRI (tractography)

Descriptive Information

Brief Title ^ICMJE

Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients vs. health subjects
Masking: Interventional
Masking Description:
Primary Purpose: Basic Science

Condition ^ICMJE

Intervention ^ICMJE

Device: functional MRI
conditioning brain activity with peripheral stimulations
Device: structural MRI
diffusion MRI and tractography for evaluating the brain structures
Device: EEG/MEG
conditioning brain activity with peripheral stimulations

Study Arms

Experimental: 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
Experimental: 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
Experimental: 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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

April 6, 2022

Estimated Primary Completion Date

November 6, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - ALS, MRC score ≥ 4 at least in one hand - Controls: no history of neurological disorders, right-handed Exclusion Criteria: - contraindication to MRI

Sex/Gender

Sexes Eligible for Study:

All

Ages

30 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Pierre-Francois Pradat, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Director: Veronique Marchand-Pauvert, PhD Institut National de la Santé Et de la Recherche Médicale, France

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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