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NCT03694132 Clinical Trial

Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

— SOM_ALS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03694132
Other study ID # C17-70
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 26, 2018
Est. completion date April 6, 2022

Study information
Verified date September 2018
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Veronique Marchand-Pauvert, PhD
Phone 142161120
Email veronique.marchand-pauvert@inserm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 52
Est. completion date April 6, 2022
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- ALS, MRC score = 4 at least in one hand

- Controls: no history of neurological disorders, right-handed

Exclusion Criteria:

- contraindication to MRI

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Pitie-Salpetriere Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Brain activity Brain parametric maps 1 hour
Secondary Brain connectivity diffusion brain MRI (tractography) 15 min
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