NCT03694132

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

November 18, 2025

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

September 28, 2018

Last Update Submit

November 14, 2025

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Brain excitabilityBrain connectivityMotor cortexSomatosensory cortex

Outcome Measures

Primary Outcomes (1)

  • Brain activity

    Brain parametric maps

    1 hour

Secondary Outcomes (1)

  • Brain connectivity

    15 min

Study Arms (3)

functional MRI

EXPERIMENTAL

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

Device: functional MRI

structural MRI

EXPERIMENTAL

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

Device: structural MRI

EEG/MEG

EXPERIMENTAL

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

Device: EEG/MEG

Interventions

functional MRIDEVICE

conditioning brain activity with peripheral stimulations

functional MRI
structural MRIDEVICE

diffusion MRI and tractography for evaluating the brain structures

structural MRI
EEG/MEGDEVICE

conditioning brain activity with peripheral stimulations

EEG/MEG

Eligibility Criteria

Age30 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailscontrols will be gender and age-matched to ALS
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Pitie-Salpetriere

Paris, 75013, France

Location

Related Publications (2)

  • 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.

    PMID: 29317192BACKGROUND

  • 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.

    PMID: 40488178RESULT

Related Links

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Pierre-Francois Pradat, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Veronique Marchand-Pauvert, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: patients vs. health subjects
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 3, 2018

Study Start

November 26, 2018

Primary Completion

December 31, 2019

Study Completion

March 31, 2021

Last Updated

November 18, 2025

Record last verified: 2021-09

Locations

FR(1)