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

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ClinicalTrials.gov Identifier: NCT03694132
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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).


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: functional MRI Device: structural MRI Device: EEG/MEG Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients vs. health subjects
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : April 6, 2022


Arm Intervention/treatment
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
Device: functional MRI
conditioning brain activity with peripheral stimulations

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




Primary Outcome Measures :
  1. Brain activity [ Time Frame: 1 hour ]
    Brain parametric maps


Secondary Outcome Measures :
  1. Brain connectivity [ Time Frame: 15 min ]
    diffusion brain MRI (tractography)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   controls will be gender and age-matched to ALS
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694132


Contacts
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Contact: Veronique Marchand-Pauvert, PhD 142161120 ext 33 veronique.marchand-pauvert@inserm.fr
Contact: Pierre-Francois Pradat, MD, PhD 142162471 ext 33 pierre-francois.pradat@aphp.fr

Locations
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France
Hopital Pitie-Salpetriere Recruiting
Paris, France, 75013
Contact: Veronique Marchand-Pauvert, PhD    142161120 ext 33    veronique.marchand-pauvert@inserm.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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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

Publications of Results:
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03694132     History of Changes
Other Study ID Numbers: C17-70
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Brain excitability
Brain connectivity
Motor cortex
Somatosensory cortex

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases