N2O: Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05469321
Collaborator
(none)
20
4

Study Details

Study Description

Brief Summary

Nitrous oxide (N2O) is a colorless, flammable, analgesic gas used in surgery and dentistry. The consumption of N2O has increased among young French people aiming to relax because of its short-lived neuropsychological effect (euphoria, depersonalization, analgesia) and its wide availability on the market.

It can be responsible in case of prolonged use and overdose of a vitamin B12 deficiency with possible neuropsychiatric complications: sensitivomotor neuropathy, myelopathy, behavioral and cognitive disorders of acute or sub-acute installation.

N2O inhibits the activitý of methionine synthase, decreases the activitý of methylmalonyl-CoA mutase leading to vitamin B12 deficiency but in addition to the interference with vitamin B12 metabolism there seems to be a direct toxicity of N20.

Myelin alteration was the typical electromyography finding but new axonal profiles were also described. Since myelopathy affects both the posterior and lateral cords, combined spinal cord sclerosis is the most common location of injury associated with N2O intoxication.

Condition or Disease Intervention/Treatment Phase
  • Other: None, pure observationnal study

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Study of Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients

patients presenting to the CHU of Nîmes for an acute or subacute neurological picture after having consumed N2O.

Other: None, pure observationnal study
None, pure observational study following the usual management of the patients

Outcome Measures

Primary Outcome Measures

  1. MRC score [baseline]

    MRCss - Medical Research Council sum score : This score assigns a rating to each muscle group: "0" = absence of visible contraction visible contractions, " 1 " = visible contractions without movement of limbs, " 2 " = insufficient 2" = insufficient movements to overcome weightlessness, "3" = movements to overcome weightlessness, "4" = movements against weightlessness and resistance, "5" = normal muscle strength.

  2. Romberg score [Baseline]

    A positive Romberg test means the presence of sensory ataxia

  3. INCAT Sensory Sum score (ISS) [Baseline]

    grades from 0 (no involvement) to 20 (severe involvement)

  4. ONLS - Overall Neuropathy Limitations Scale [Baseline]

    Overall Neuropathy Limitation Scale = arm scale (range 0 to 5) + leg scale (range 0 to 7); (range: 0 (no disability) to 12 (maximum disability)

  5. Rankin score [Baseline]

    disability measurement score from 0 (none) to 6 (death)

  6. vitamin B12 level [baseline]

    vitamin B12 level in µmom/L

  7. methyl malonic acid level [baseline]

    methyl-malonic acid level

  8. electroneuromyogram [baseline]

    Normal Yes/No

  9. Cerebral MRI [baseline]

    lesions yes/No

  10. Pan-medullary MRI [baseline]

    lesions yes/No

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

patients presenting to the CHU of Nîmes with an acute or sub-acute neurological picture after having consumed N2O

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT05469321
Other Study ID Numbers:
  • Local/2022/II-03
First Posted:
Jul 21, 2022
Last Update Posted:
Jul 21, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 21, 2022