Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide

NCT05469321 | Unknown

• 1 other identifier: Local/2022/II-03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy

Outcome Measures

Primary Outcomes (10)

• MRC score

  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.

  baseline

• Romberg score

  A positive Romberg test means the presence of sensory ataxia

  Baseline

• INCAT Sensory Sum score (ISS)

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

  Baseline

• ONLS - Overall Neuropathy Limitations Scale

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

  Baseline

• Rankin score

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

  Baseline

• vitamin B12 level

  vitamin B12 level in µmom/L

  baseline

• methyl malonic acid level

  methyl-malonic acid level

  baseline

• electroneuromyogram

  Normal Yes/No

  baseline

• Cerebral MRI

  lesions yes/No

  baseline

• Pan-medullary MRI

  lesions yes/No

  baseline

Study Arms (1)

Patients

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

Other: None, pure observationnal study

Interventions

None, pure observationnal study OTHER

None, pure observational study following the usual management of the patients

Patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Central Study Contacts

Ioana Maria ION

CONTACT

06 22 920361; ioanamaria@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 21, 2022
• Study Start: August 22, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

FR (1)