Amyotrophic Lateral SclerosisMOTOBLINKNCT06206629
Contralateral R1 in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Hospices Civils de Lyon at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- blink reflex evaluation
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Feb 2024to 5 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital neurologique Pierre Wertheimer
Bron, Rhone, 69500
CHU de Nantes
Nantes, 44093
About this study
Official title: 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- blink reflex evaluation
- Keywords
- Amyotrophic lateral sclerosis, ALS, Electroneuromyography, ENMG
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blink reflex evaluationDiagnostic test
A blink reflex evaluation will be performed in all subjects
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Patients with ALS (Awaji criteria) Receives: 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. Receives: Diagnostic Test: blink reflex evaluation | |
| Healthy volunteers | Healthy volunteers who will undergo a blink reflex evaluation on ENMG. Receives: Diagnostic Test: blink reflex evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start15 Feb 2024
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206629
- Sponsor's protocol ID
- 69HCL23_1291
- Acronym
- MOTOBLINK
- Status last verified
- Oct 2024
- First submitted
- 4 Jan 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Contralateral R1 Component of the Blink Reflex in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06206629
- Acronym / sponsor ID
- MOTOBLINK / 69HCL23_1291
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, ALS, Electroneuromyography, ENMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | Diagnostic Test: blink reflex evaluationPatients with ALS (Awaji criteria) |
| Non-ALS patients | – | Diagnostic Test: blink reflex evaluationPatients referred to the neurophysiology unit for a suspicion of ALS du to motor weakness, but in whom the diagnosis is ruled out. |
| Healthy volunteers | – | Diagnostic Test: blink reflex evaluationHealthy volunteers who will undergo a blink reflex evaluation on ENMG. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- For patients
- Aged 18 to 99 years old
- Referred for suspected motor neuromuscular disease
- Collection of non-opposition
- Aged 18 to 99 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blink reflex evaluationA blink reflex evaluation will be performed in all subjects | Diagnostic test | ALS patients, Healthy volunteers, Non-ALS patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a contralateral R1 component on blink reflex evaluation. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.