Contralateral R1 in Amyotrophic Lateral Sclerosis

NCT06206629 | Completed

• 1 other identifier: 69HCL23_1291
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis; ALS; Electroneuromyography; ENMG

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

ALS patients

Patients with ALS (Awaji criteria)

Diagnostic Test: blink reflex evaluation

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

Healthy volunteers

Healthy volunteers who will undergo a blink reflex evaluation on ENMG.

Diagnostic Test: blink reflex evaluation

Interventions

blink reflex evaluation DIAGNOSTIC_TEST

A blink reflex evaluation will be performed in all subjects

ALS patients; Healthy volunteers; Non-ALS patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital neurologique Pierre Wertheimer

Bron, Rhone, 69500, France

Location

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: February 15, 2024
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)