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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

functional MRI

structural MRI

EEG/MEG

About this trial

This is an interventional basic science trial for Amyotrophic Lateral Sclerosis focused on measuring Brain excitability, Brain connectivity, Motor cortex, Somatosensory cortex

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Hopital Pitie-SalpetriereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

functional MRI

structural MRI

EEG/MEG

Arm 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

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

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

Outcomes

Primary Outcome Measures

Brain activity

Brain parametric maps

Secondary Outcome Measures

Brain connectivity

diffusion brain MRI (tractography)

Full Information

NCT ID

NCT03694132

First Posted

September 28, 2018

Last Updated

December 20, 2018

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03694132

Brief Title

Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

Acronym

SOM_ALS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 26, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

April 6, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

Brain excitability, Brain connectivity, Motor cortex, Somatosensory cortex

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

patients vs. health subjects

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

functional MRI

Arm Type

Experimental

Arm 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

Arm Title

structural MRI

Arm Type

Experimental

Arm 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

Arm Title

EEG/MEG

Arm Type

Experimental

Arm 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

Intervention Type

Device

Intervention Name(s)

functional MRI

Intervention Description

conditioning brain activity with peripheral stimulations

Intervention Type

Device

Intervention Name(s)

structural MRI

Intervention Description

diffusion MRI and tractography for evaluating the brain structures

Intervention Type

Device

Intervention Name(s)

EEG/MEG

Intervention Description

conditioning brain activity with peripheral stimulations

Primary Outcome Measure Information:

Title

Brain activity

Description

Brain parametric maps

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Brain connectivity

Description

diffusion brain MRI (tractography)

Time Frame

15 min

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

controls will be gender and age-matched to ALS

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veronique Marchand-Pauvert, PhD

Phone

142161120

Ext

veronique.marchand-pauvert@inserm.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre-Francois Pradat, MD, PhD

Phone

142162471

Ext

pierre-francois.pradat@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre-Francois Pradat, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Veronique Marchand-Pauvert, PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Pitie-Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veronique Marchand-Pauvert, PhD

Phone

142161120

Ext

veronique.marchand-pauvert@inserm.fr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29317192

Citation

Sangari S, Giron A, Marrelec G, Pradat PF, Marchand-Pauvert V. Abnormal cortical brain integration of somatosensory afferents in ALS. Clin Neurophysiol. 2018 Apr;129(4):874-884. doi: 10.1016/j.clinph.2017.12.008. Epub 2017 Dec 24.

Results Reference

result

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Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

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