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Clinical Trials/NCT05469321
NCT05469321TerminatedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country20 target enrollmentStarted: August 22, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
electroneuromyogram

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Patients

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

Intervention: None, pure observationnal study (Other)

Outcomes

Primary Outcomes

electroneuromyogram

Time Frame: baseline

Normal Yes/No

INCAT Sensory Sum score (ISS)

Time Frame: Baseline

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

ONLS - Overall Neuropathy Limitations Scale

Time Frame: 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)

vitamin B12 level

Time Frame: baseline

vitamin B12 level in µmom/L

MRC score

Time Frame: 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.

Pan-medullary MRI

Time Frame: baseline

lesions yes/No

Romberg score

Time Frame: Baseline

A positive Romberg test means the presence of sensory ataxia

Rankin score

Time Frame: Baseline

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

Cerebral MRI

Time Frame: baseline

lesions yes/No

methyl malonic acid level

Time Frame: baseline

methyl-malonic acid level

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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