Neurology DepartmentEPI-NOXNCT05329909
Epidemiology of Neurological Complications to Nitrous Oxide Poisoning
An observational study of Neurology Department, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
N2O inactivates vitamin B12, impairing its ability to act as a cofactor of methionine synthase. In addition, the elimination of vitamin B12 is increased. Neurological damage is similar to that described in combined sclerosis of the marrow, and are probably related to induce vitamin B12 deficiency. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neurology Department
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2022to 31 Aug 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cohort of patients who have been exposed to N2O and have neurological disorders
Who may be able to join
- Adult patient (≥16 years)
- Hospitalized or having consulted with the departments of Neurology or Internal Medicine for neurological phenomena related to the consumption of N2O. The neurological phenomena included are usually: neuropathies or myelopathies, However, the existence of other neurological or psychiatric signs is not a factor of exclusion: for example, headaches or cognitive or psychiatric disorders with acute onset.
- Exposure to N2O for recreational or medical reasons (Meopa anesthesia).
- Lack of alternative diagnosis other than N2O poisoning
- Consultation for neurological disorders between 01/01/2018 and 31/12/2021
Who cannot join
- Minor subjects or subjects subject to a legal protection measure (guardianship, curators) during the consultation.
- Refusal to include in a study explained in the file
- Absence of N2O consumption during the 6 months preceding the appearance of signs
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital DELAFONTAINE
Saint-Denis, Île-de-France Region, 93200
Stéphanie Cossec, 0142356140 ext. 6962, coordination.rechercheclinique@ghtpdfr.fr
Mickaël Bonnan
About this study
N2O inactivates vitamin B12, impairing its ability to act as a cofactor of methionine synthase. In addition, the elimination of vitamin B12 is increased. Neurological damage is similar to that described in combined sclerosis of the marrow, and are probably related to induce vitamin B12 deficiency. The use of N2O can then precipitate the rapid appearance of signs (neurological, psychiatric and hematological) related to a true and/ or functional vitamin B12 deficiency.
In 1978, RB Layzer described the first 3 cases of peripheral neuropathy secondary to nitrous oxide (N2O) consumption. In 2016, a team collected the 91 published cases: among these, 72 had neurological complications, and 52 had a concentration of vitamin B12 considered "low" or "normal-low"
Read more
Since then, consumption patterns seem changed due to: an increasing ease of access, the change of container (packaging in cartridge 8 grams versus bottle of 600 grams) and a usually occasional and festive consumption that seems to become solitary and regular, This change in consumption patterns is explained by an increased incidence of neurological complications, although no epidemiological work is yet available.
The objective of this work is to describe the epidemiology of this condition, to correlate it with major recent social phenomena (confinement related to the SARS-Cov2 pandemic), and finally to compare the incidence of myelopathies secondary to N2O with the incidence of other frequent inflammatory neurological diseases (autoimmune myelitis and Guillain-Barré syndrome).
- Conditions
- Neurology Department
- Keywords
- nitrous oxide poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
sexe
describe the epidemiology of neurological complications to nitrous oxide poisoning
Measured: Day 1
age
describe the epidemiology of neurological complications to nitrous oxide poisoning
Measured: Day 1
place to live
describe the epidemiology of neurological complications to nitrous oxide poisoning
Measured: Day 1
Occupational status
describe the epidemiology of neurological complications to nitrous oxide poisoning
Measured: Day 1
consumption of toxic substances (alcohol, tobacco, cannabis)
describe the epidemiology of neurological complications to nitrous oxide poisoning
Measured: Day 1
Secondary outcomes (2)
Date and nature of first symptoms
correlate epidemiology with major recent social phenomena
Measured: Day 1
consumption mode and quantity
correlate epidemiology with major recent social phenomena
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 posted15 Apr 2022
- Study start10 Apr 2022
- Primary completion10 Jul 2022
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurology DepartmentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329909
- Sponsor's protocol ID
- CHSD_0023_NEURO
- Other IDs
- 2022-A00718-35
- Acronym
- EPI-NOX
- Status last verified
- May 2022
- First submitted
- 8 Apr 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Layzer RB, Fishman RA, Schafer JA. Neuropathy following abuse of nitrous oxide. Neurology. 1978 May;28(5):504-6. doi: 10.1212/wnl.28.5.504.
PubMed 205816Sanders RD, Weimann J, Maze M. Biologic effects of nitrous oxide: a mechanistic and toxicologic review. Anesthesiology. 2008 Oct;109(4):707-22. doi: 10.1097/ALN.0b013e3181870a17.
PubMed 18813051Garakani A, Jaffe RJ, Savla D, Welch AK, Protin CA, Bryson EO, McDowell DM. Neurologic, psychiatric, and other medical manifestations of nitrous oxide abuse: A systematic review of the case literature. Am J Addict. 2016 Aug;25(5):358-69. doi: 10.1111/ajad.12372. Epub 2016 Apr 1.
PubMed 27037733Vollhardt R, Mazoyer J, Bernardaud L, Haddad A, Jaubert P, Coman I, Manceau P, Mongin M, Degos B. Neurological consequences of recreational nitrous oxide abuse during SARS-CoV-2 pandemic. J Neurol. 2022 Apr;269(4):1921-1926. doi: 10.1007/s00415-021-10748-7. Epub 2021 Aug 21.
PubMed 34417869
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Neurological Complications to Nitrous Oxide Poisoning
- ClinicalTrials.gov ID
- NCT05329909
- Acronym / sponsor ID
- EPI-NOX / CHSD_0023_NEURO
- Conditions
- Neurology Department
- Keywords
- nitrous oxide poisoning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 15 Apr 2022 (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.
N2O inactivates vitamin B12, impairing its ability to act as a cofactor of methionine synthase. In addition, the elimination of vitamin B12 is increased. Neurological damage is similar to that described in combined sclerosis of the marrow, and are probably related to induce vitamin B12 deficiency. The use of N2O can then precipitate the rapid appearance of signs (neurological, psychiatric and hematological) related to a true and/ or functional vitamin B12 deficiency.
In 1978, RB Layzer described the first 3 cases of peripheral neuropathy secondary to nitrous oxide (N2O) consumption. In 2016, a team collected the 91 published cases: among these, 72 had neurological complications, and 52 had a concentration of vitamin B12 considered "low" or "normal-low"
Since then, consumption patterns seem changed due to: an increasing ease of access, the change of container (packaging in cartridge 8 grams versus bottle of 600 grams) and a usually occasional and festive consumption that seems to become solitary and regular, This change in consumption patterns is explained by an increased incidence of neurological complications, although no epidemiological work is yet available.
The objective of this work is to describe the epidemiology of this condition, to correlate it with major recent social phenomena (confinement related to the SARS-Cov2 pandemic), and finally to compare the incidence of myelopathies secondary to N2O with the incidence of other frequent inflammatory neurological diseases (autoimmune myelitis and Guillain-Barré syndrome).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cohort of patients who have been exposed to N2O and have neurological disorders
Key inclusion criteria (5 listed)
- Adult patient (≥16 years)
- Hospitalized or having consulted with the departments of Neurology or Internal Medicine for neurological phenomena related to the consumption of N2O. The neurological phenomena included are usually: neuropathies or myelopathies, However, the existence of other neurological or psychiatric signs is not a factor of exclusion: for example, headaches or cognitive or psychiatric disorders with acute onset.
- Exposure to N2O for recreational or medical reasons (Meopa anesthesia).
- Lack of alternative diagnosis other than N2O poisoning
- Consultation for neurological disorders between 01/01/2018 and 31/12/2021
Key exclusion criteria (3 listed)
- Minor subjects or subjects subject to a legal protection measure (guardianship, curators) during the consultation.
- Refusal to include in a study explained in the file
- Absence of N2O consumption during the 6 months preceding the appearance of signs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sexe
Time frame: Day 1
describe the epidemiology of neurological complications to nitrous oxide poisoning
age
Time frame: Day 1
describe the epidemiology of neurological complications to nitrous oxide poisoning
place to live
Time frame: Day 1
describe the epidemiology of neurological complications to nitrous oxide poisoning
Occupational status
Time frame: Day 1
describe the epidemiology of neurological complications to nitrous oxide poisoning
consumption of toxic substances (alcohol, tobacco, cannabis)
Time frame: Day 1
describe the epidemiology of neurological complications to nitrous oxide poisoning
2 secondary outcomes
Date and nature of first symptoms
Time frame: Day 1
consumption mode and quantity
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Background: PubMed 205816Layzer RB, Fishman RA, Schafer JA. Neuropathy following abuse of nitrous oxide. Neurology. 1978 May;28(5):504-6. doi: 10.1212/wnl.28.5.504.
- Background: PubMed 18813051Sanders RD, Weimann J, Maze M. Biologic effects of nitrous oxide: a mechanistic and toxicologic review. Anesthesiology. 2008 Oct;109(4):707-22. doi: 10.1097/ALN.0b013e3181870a17.
- Background: PubMed 27037733Garakani A, Jaffe RJ, Savla D, Welch AK, Protin CA, Bryson EO, McDowell DM. Neurologic, psychiatric, and other medical manifestations of nitrous oxide abuse: A systematic review of the case literature. Am J Addict. 2016 Aug;25(5):358-69. doi: 10.1111/ajad.12372. Epub 2016 Apr 1.
- Background: PubMed 34417869Vollhardt R, Mazoyer J, Bernardaud L, Haddad A, Jaubert P, Coman I, Manceau P, Mongin M, Degos B. Neurological consequences of recreational nitrous oxide abuse during SARS-CoV-2 pandemic. J Neurol. 2022 Apr;269(4):1921-1926. doi: 10.1007/s00415-021-10748-7. Epub 2021 Aug 21.
Related trials for Neurology Department
RecruitingObservational study
Observational Study on "Functional Overlay" in Patients With Movement Disorders
Conversion Disorder, Parkinson Disease
Recruiting
Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study
Ischemic Stroke, Acute, Rehabilitation Outcome
Active, not recruitingPhase 4
Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia
Trigeminal Neuralgia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurology Department, run by Centre Hospitalier de Saint-Denis at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mickael BONNAN, MD (01 42 35 62 97, mickael.bonnan@ch-stdenis.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexe (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329909, which also lists 4 linked publications.
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 11 Aug 2022.