Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03694132

Acronym

SOM_ALS

Enrollment

Registered

2018-10-03

Start date

2018-11-26

Completion date

2021-03-31

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Brain excitability, Brain connectivity, Motor cortex, Somatosensory cortex

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).

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.

Interventions

DEVICEfunctional MRI

conditioning brain activity with peripheral stimulations

DEVICEstructural MRI

diffusion MRI and tractography for evaluating the brain structures

DEVICEEEG/MEG

conditioning brain activity with peripheral stimulations

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

patients vs. health subjects

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* contraindication to MRI

Design outcomes

Primary

Measure	Time frame	Description
Brain activity	1 hour	Brain parametric maps

Secondary

Measure	Time frame	Description
Brain connectivity	15 min	diffusion brain MRI (tractography)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026