- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469321
Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide (N2O)
A Retrospective Study of Neurological Impairment in a Young Population Exposed to Recreational Nitrous Oxide
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
patients presenting to the CHU of Nîmes with an acute or sub-acute neurological picture after having consumed N2O
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
patients presenting to the CHU of Nîmes for an acute or subacute neurological picture after having consumed N2O.
|
None, pure observational study following the usual management of the patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
|
Romberg score
Time Frame: Baseline
|
A positive Romberg test means the presence of sensory ataxia
|
Baseline
|
|
INCAT Sensory Sum score (ISS)
Time Frame: Baseline
|
grades from 0 (no involvement) to 20 (severe involvement)
|
Baseline
|
|
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)
|
Baseline
|
|
Rankin score
Time Frame: Baseline
|
disability measurement score from 0 (none) to 6 (death)
|
Baseline
|
|
vitamin B12 level
Time Frame: baseline
|
vitamin B12 level in µmom/L
|
baseline
|
|
methyl malonic acid level
Time Frame: baseline
|
methyl-malonic acid level
|
baseline
|
|
electroneuromyogram
Time Frame: baseline
|
Normal Yes/No
|
baseline
|
|
Cerebral MRI
Time Frame: baseline
|
lesions yes/No
|
baseline
|
|
Pan-medullary MRI
Time Frame: baseline
|
lesions yes/No
|
baseline
|
Collaborators and Investigators
Investigators
- Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nîmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Local/2022/II-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuropathy
-
Wake Forest University Health SciencesNot yet recruiting
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingChemotherapy-Induced Peripheral Neuropathy | Paclitaxel-Induced Peripheral Neuropathy | Refractory Chemotherapy-Induced Peripheral Neuropathy
-
Arash Asher, MDVoxxLifeCompletedNeuropathy | Chemotherapy-induced Peripheral Neuropathy | Neuropathy;PeripheralUnited States
-
Dana-Farber Cancer InstitutePaxman Coolers LimitedRecruitingChemotherapy-induced Peripheral Neuropathy | CIPN - Chemotherapy-Induced Peripheral Neuropathy | Taxane-Induced Peripheral NeuropathyUnited States
-
Dana-Farber Cancer InstituteRecruitingNeuropathy | Peripheral Neuropathies | Peripheral Neuropathy Due to Chemotherapy | Chemotherapy Induced Peripheral Neuropathy (CIPN)United States
-
Endeavor HealthOctapharma USA, Inc.RecruitingSmall Fiber Neuropathy | Autoimmune Small Fiber Neuropathy | Inflammatory Polyneuropathy | Immune-Mediated NeuropathyUnited States
-
Centre Hospitalier de BlignyHopital Forcilles; AgenTNot yet recruitingTaxane-induced Peripheral Neuropathy | Chemotherapy Induced Neuropathic Pain | Neuropathy Toxic | Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
-
Beth Israel Deaconess Medical CenterPhoenix Neurological Associates, LTDCompletedSmall Fiber Neuropathy | Idiopathic Peripheral NeuropathyUnited States
-
Nihon Pharmaceutical Co., LtdCompletedMultifocal Motor NeuropathyJapan
-
University of AarhusCompletedMultifocal Motor NeuropathyDenmark
Clinical Trials on None, pure observationnal study
-
Centre Hospitalier Universitaire de NīmesNot yet recruiting
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Centre Hospitalier Universitaire de NīmesWithdrawnChronic Inflammatory Demyelinating PolyradiculoneuropathyFrance
-
Centre Hospitalier Universitaire de NīmesCompletedCerebellar AtaxiaFrance
-
Centre Hospitalier Universitaire de NīmesCompletedStroke | Hemorrhage | Cerebral Amyloid AngiopathyFrance
-
Centre Hospitalier Universitaire de NīmesCompletedStroke | Stenoses, CarotidFrance
-
Centre Hospitalier Universitaire de NīmesNot yet recruitingCerebral Hemorrhage | Acute Lobar Haematoma
-
Centre Hospitalier Universitaire de NīmesCompletedCerebral Amyloid Angiopathy | Hypertensive ArteriopathyFrance
-
Centre Hospitalier Universitaire de NīmesCompletedCerebral Amyloid Angiopathy | SiderosisFrance
-
Kansas City Heart Rhythm Research FoundationNot yet recruitingCardiac ArrhythmiasUnited States