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

Study Purpose:

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).

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Device

Intervention Name:

functional MRI, structural MRI, EEG/MEG

Placebo:

No

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Pierre-Francois Pradat, MD, PhD, Assistance Publique - Hôpitaux de Paris, Veronique Marchand-Pauvert, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Clinicaltrials.gov ID:

NCT03694132

Neals Affiliated?

No

Coordinating Center Contact Information

Veronique Marchand-Pauvert, PhD / email hidden; JavaScript is required / 142161120

Full Study Summary:

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.

Study Sponsor:

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

Estimated Enrollment:

52

Estimated Study Start Date:

11 / 26 / 2018

Estimated Study Completion Date:

04 / 06 / 2022

Posting Last Modified Date:

12 / 21 / 2018

Date Study Added to neals.org:

10 / 03 / 2018

Minimum Age:

30 Years

Maximum Age:

80 Years

Inclusion Criteria:

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

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

Exclusion Criteria:

- contraindication to MRI

Hopital Pitie-Salpetriere | Recruiting

Veronique Marchand-Pauvert, PhD / 142161120 Ext. 33 / email hidden; JavaScript is required

Paris 75013
France