Contralateral R1 in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— MOTOBLINK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206629
• Other study ID #: 69HCL23_1291
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• blink reflex evaluation
A blink reflex evaluation will be performed in all subjects

Locations

Country	Name	City	State
France	Hôpital neurologique Pierre Wertheimer	Bron	Rhone
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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