Contralateral R1 in Amyotrophic Lateral Sclerosis

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: blink reflex evaluation

• Registration Number: NCT06206629
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Study Start: 2024-02-15
• Primary Completion: 2024-09-05
• Study Completion: 2024-09-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ALS patients	blink reflex evaluation	Patients with ALS (Awaji criteria)
Healthy volunteers	blink reflex evaluation	Healthy volunteers who will undergo a blink reflex evaluation on ENMG.
Non-ALS patients	blink reflex evaluation	Patients referred to the neurophysiology unit for a suspicion of ALS du to motor weakness, but in whom the diagnosis is ruled out.

Primary Outcome Measures

Name	Time	Method
Presence of a contralateral R1 component on blink reflex evaluation.	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.

Trial Locations

Locations (2)

Hôpital neurologique Pierre Wertheimer; 🇫🇷 Bron, Rhone, France

CHU de Nantes; 🇫🇷 Nantes, France