Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide

Neuropathy Clinical Trial

— N2O  

Official title:

A Retrospective Study of Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469321
• Other study ID #: Local/2022/II-03
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Ioana Maria ION
• Phone: 06 22 920361
• Email: ioanamaria[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuropathy

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Romberg score	A positive Romberg test means the presence of sensory ataxia	Baseline
Primary	INCAT Sensory Sum score (ISS)	grades from 0 (no involvement) to 20 (severe involvement)	Baseline
Primary	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
Primary	Rankin score	disability measurement score from 0 (none) to 6 (death)	Baseline
Primary	vitamin B12 level	vitamin B12 level in µmom/L	baseline
Primary	methyl malonic acid level	methyl-malonic acid level	baseline
Primary	electroneuromyogram	Normal Yes/No	baseline
Primary	Cerebral MRI	lesions yes/No	baseline
Primary	Pan-medullary MRI	lesions yes/No	baseline