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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05469321
Other study ID # Local/2022/II-03
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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 -

Study Design


Related Conditions & MeSH terms


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
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