Neurological recovery after nitrous oxide–related B12 spinal cord damage
Longitudinal Assessment of Neurological Recovery in Patients Following Nitrous Oxide Abuse
This project will see how people aged 16–40 recover neurologically after nitrous oxide–related vitamin B12 damage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Locations | 3 sites (Birmingham and 2 other locations) |
| Trial ID | NCT05714917 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling patients who present with new paresthesia, weakness, ataxia or gait disturbance after nitrous oxide use and have consultant-confirmed NOS-induced neurological damage. Baseline data (neurological exam, routine bloods including B12, and MRI) will be collected ideally while patients are in hospital, and standard clinical care including B12 injections will be recorded. Participants will be followed longitudinally to document functional recovery and treatments received, and a subset with mental health difficulties will be invited to qualitative interviews. No experimental interventions are given; care follows local clinical guidelines.
Who should consider this trial
Good fit: Ideal candidates are people aged 16–40 with recent onset paresthesia, weakness, ataxia or gait disturbance after nitrous oxide use who have a consultant neurologist–confirmed diagnosis and can read and write English.
Not a fit: Patients with alternative causes of neuropathy or pre-existing neurodegenerative disorders, or those outside the 16–40 age range, are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the study could clarify typical recovery timelines and treatment patterns and help guide future recommendations for B12 replacement and follow-up.
How similar studies have performed: Small case series and retrospective reports have described improvement after B12 replacement, but prospective longitudinal data on functional recovery are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient first presented with paraesthesia, weakness, ataxia or gait disturbance with a history of NOS use (age limit 16-40) as of 19/08/2024 * Patients who can read and write in English, so that they can complete the questionnaires. * Patients must have received a definitive consultant neurologist confirmed diagnosis of NOS-induced neurological damage. This is possible as all eligible patients will have been reviewed by the neurology team prior to study involvement. Exclusion Criteria: •Other causes of previous neuropathy or neurodegeneration indicated. Qualitative Interview Study: * Patients currently taking part in the longitudinal study. * Patients who report previously (clinical history) or currently (PHQ-2, clinical history) experiencing mental health difficulties.
Where this trial is running
Birmingham and 2 other locations
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Salford Royal NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nikos Evangelou, FRCP, DPhil
- Email: nikos.evangelou@nottingham.ac.uk
- Phone: 07715172966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.