Contralateral R1 in Amyotrophic Lateral Sclerosis (MOTOBLINK)

Evaluation of Contralateral R1 Component of the Blink Reflex in Patients With Amyotrophic Lateral Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Diagnostic test: blink reflex evaluation

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes
  • Rhone
    • Bron, Rhone, France, 69500
      • Hopital Neurologique Pierre Wertheimer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of a contralateral R1 component on blink reflex evaluation.	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.	Day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: ALS; Amyotrophic lateral sclerosis; Electroneuromyography; ENMG
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 69HCL23_1291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No