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

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Hospices Civils de Lyon

Tracking Information

First Submitted Date

January 4, 2024

First Posted Date

January 16, 2024

Last Update Posted Date

February 16, 2024

Actual Study Start Date

February 15, 2024

Estimated Primary Completion Date

February 15, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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.

Original Primary Outcome Measures

Presence of a contralateral R1 component on blink reflex evaluation. [ Time Frame: The outcome will be measured during the first and only ENMG performed in this study. ]

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Contralateral R1 in Amyotrophic Lateral Sclerosis

Official Title

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

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 Provided

Study Type

Observational

Study Design

Observational Model: Case-Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition

Amyotrophic Lateral Sclerosis

Intervention

Diagnostic Test: blink reflex evaluation

A blink reflex evaluation will be performed in all subjects

Study Groups/Cohorts

ALS patients
Patients with ALS (Awaji criteria)

Intervention: 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.

Intervention: Diagnostic Test: blink reflex evaluation
Healthy volunteers
Healthy volunteers who will undergo a blink reflex evaluation on ENMG.

Intervention: Diagnostic Test: blink reflex evaluation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

120

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

February 15, 2025

Estimated Primary Completion Date

February 15, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 99 Years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Contacts

Listed Location Countries

France

Removed Location Countries

Administrative Information

NCT Number

NCT06206629

Other Study ID Numbers

69HCL23_1291

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Current Responsible Party

Hospices Civils de Lyon

Original Responsible Party

Same as current

Current Study Sponsor

Hospices Civils de Lyon

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Not Provided

PRS Account

Hospices Civils de Lyon

Verification Date

February 2024

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