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Contralateral R1 in Amyotrophic Lateral Sclerosis (MOTOBLINK)

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ClinicalTrials.gov Identifier: NCT06206629
Recruitment Status : Recruiting
First Posted : January 16, 2024
Last Update Posted : February 16, 2024
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting both upper and lower motor neurons. Electroneuromyography is an important tool for the diagnosis. Previous studies have shown that different components of the blink reflex, such as the latencies of homo- and contralateral R2 responses can be affected. Studies have found that a contralateral R1 component can appear in neurological diseases with affection of the central nervous system especially upper motor neuron, such as HTLV1 infection. Thus, you aim to determine if a contralateral R1 component could be present in ALS.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Diagnostic Test: blink reflex evaluation

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Contralateral R1 Component of the Blink Reflex in Patients With Amyotrophic Lateral Sclerosis
Actual Study Start Date : February 15, 2024
Estimated Primary Completion Date : February 15, 2025
Estimated Study Completion Date : February 15, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ALS patients
Patients with ALS (Awaji criteria)
 Diagnostic Test: blink reflex evaluation
A blink reflex evaluation will be performed in all subjects
Non-ALS patients
Patients referred to the neurophysiology unit for a suspicion of ALS du to motor weakness, but in whom the diagnosis is ruled out.
 Diagnostic Test: blink reflex evaluation
A blink reflex evaluation will be performed in all subjects
Healthy volunteers
Healthy volunteers who will undergo a blink reflex evaluation on ENMG.
 Diagnostic Test: blink reflex evaluation
A blink reflex evaluation will be performed in all subjects


Outcome Measures
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Primary Outcome Measures :
  1. Presence of a contralateral R1 component on blink reflex evaluation. [ Time Frame: Day 1 ]

    A blink reflex evaluation will be performed in all subjects : Blink reflex will be recorded with surface electrodes placed medially over the lower part of the eyelid, on the orbicularis oculi muscle, with a reference electrode 2 cm laterally. Stimuli will be delivered to the supraorbital nerve by surface electrodes with an intensity required to generate a consistent homolateral R1 response.

    A contralateral R1 component will be defined as an early compound muscle action potential recorded in the contralateral orbicularis oculi muscle.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to the neurophysiology unit from the Hospices civils de Lyon, for a suspicion of motor neuron disease.

And healthy volunteers for the third group.

Criteria

Inclusion Criteria:

For patients

  • Aged 18 to 99 years old
  • Referred for suspected motor neuromuscular disease
  • Collection of non-opposition

For healthy subjects:

  • Aged 18 to 99 years old
  • Absence of any neurological pathology
  • Collection of non-opposition

Exclusion Criteria:

  • Previous damage linked to another cause of the cranial nerves
  • Prior brainstem lesions
  • Persons deprived of liberty by a judicial or administrative decision
  • Patient under judicial protection, unable to express consent
Contacts and Locations
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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): NCT06206629


Locations
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France
Hôpital neurologique Pierre Wertheimer Recruiting
Bron, Rhone, France, 69500
Contact: Antoine PEGAT, Dr    0472118062 ext +33    antoine.pegat@chu-lyon.fr   
Principal Investigator: Antoine Pegat, Dr         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Yann Pereon, Pr    0240083616 ext +33    Yann.pereon@univ-nantes.fr   
Principal Investigator: Yann Pereon, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT06206629    
Other Study ID Numbers: 69HCL23_1291
First Posted: January 16, 2024    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Hospices Civils de Lyon:
Amyotrophic lateral sclerosis
ALS
Electroneuromyography
ENMG
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases