Amyotrophic Lateral SclerosisSOM_ALSNCT03694132
Brain Excitability and Connectivity in Sensory-motor Pathways in ALS
A study testing functional MRI, structural MRI and EEG/MEG in people with Amyotrophic Lateral Sclerosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- functional MRI, structural MRI and EEG/MEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALS, MRC score ≥ 4 at least in one hand
- Controls: no history of neurological disorders, right-handed
Who cannot join
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology
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).
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- functional MRI, structural MRI, EEG/MEG
- Keywords
- Brain excitability, Brain connectivity, Motor cortex, Somatosensory cortex
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional MRIDevice
conditioning brain activity with peripheral stimulations
structural MRIDevice
diffusion MRI and tractography for evaluating the brain structures
EEG/MEGDevice
conditioning brain activity with peripheral stimulations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: EEG/MEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
Brain parametric maps
Measured: 1 hour
Secondary outcomes (1)
Brain connectivity
diffusion brain MRI (tractography)
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start26 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patients vs. health subjects
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre-Francois Pradat, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisVeronique Marchand-Pauvert, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694132
- Sponsor's protocol ID
- C17-70
- Acronym
- SOM_ALS
- Status last verified
- Sep 2021
- First submitted
- 28 Sep 2018
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29317192Benetton 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.
PubMed 40488178
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology
- ClinicalTrials.gov ID
- NCT03694132
- Acronym / sponsor ID
- SOM_ALS / C17-70
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Brain excitability, Brain connectivity, Motor cortex, Somatosensory cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- patients vs. health subjects
| Arm | Type | Receives |
|---|---|---|
| functional MRI | Experimental | Device: functional MRIa 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 |
| structural MRI | Experimental | Device: structural MRIa 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 |
| EEG/MEG | Experimental | Device: EEG/MEGa 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ALS, MRC score ≥ 4 at least in one hand
- Controls: no history of neurological disorders, right-handed
Key exclusion criteria (1 listed)
- contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional MRIconditioning brain activity with peripheral stimulations | Device | functional MRI |
| structural MRIdiffusion MRI and tractography for evaluating the brain structures | Device | structural MRI |
| EEG/MEGconditioning brain activity with peripheral stimulations | Device | EEG/MEG |
Primary outcome
Brain activity
Time frame: 1 hour
Brain parametric maps
1 secondary outcome
Brain connectivity
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 29317192Sangari 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.
- Results publication: PubMed 40488178Benetton 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.
- This paper reports resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Francois Pradat, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Veronique Marchand-Pauvert, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional MRI, structural MRI and EEG/MEG in people with Amyotrophic Lateral Sclerosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694132, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.