Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

NCT ID: NCT03694132

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

patients vs. health subjects
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

functional MRI

Intervention Type DEVICE

conditioning brain activity with peripheral stimulations

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

Group Type EXPERIMENTAL

structural MRI

Intervention Type DEVICE

diffusion MRI and tractography for evaluating the brain structures

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

Group Type EXPERIMENTAL

EEG/MEG

Intervention Type DEVICE

conditioning brain activity with peripheral stimulations

Interventions

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functional MRI

conditioning brain activity with peripheral stimulations

Intervention Type DEVICE

structural MRI

diffusion MRI and tractography for evaluating the brain structures

Intervention Type DEVICE

EEG/MEG

conditioning brain activity with peripheral stimulations

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* contraindication to MRI
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Francois Pradat, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Veronique Marchand-Pauvert, PhD

Role: STUDY_DIRECTOR

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

Locations

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Hopital Pitie-Salpetriere

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29317192 (View on PubMed)

Benetton C, Preuilh A, Khamaysa M, Chaumon M, Lackmy-Vallee A, Er A, Pelegrini-Issac M, Querin G, Rouaux C, Pradat PF, Marchand-Pauvert V. Encephalography cross-frequency coupling and brain alteration in amyotrophic lateral sclerosis. Brain Commun. 2025 Jun 6;7(3):fcaf192. doi: 10.1093/braincomms/fcaf192. eCollection 2025.

Reference Type RESULT
PMID: 40488178 (View on PubMed)

Related Links

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Other Identifiers

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C17-70

Identifier Type: -

Identifier Source: org_study_id

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