Actively Recruiting

Age: 16Years - 40Years
All Genders
ID05714917

Longitudinal Assessment of Neurological Recovery in Patients Following Nitrous Oxide Abuse

Led by Nottingham University Hospitals NHS Trust · Updated on 2025-07-25

100

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nottingham University Hospitals NHS Trust

Lead Sponsor

B

Barts & The London NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying neurological recovery in patients who have experienced nerve damage caused by nitrous oxide (NOS) abuse. Nitrous oxide is a commonly used recreational drug, especially among young people aged 16 to 24 in the UK. It can inactivate vitamin B12, which is essential for nerve health, leading to symptoms like tingling, weakness, and coordination problems. This study aims to better understand the severity and recovery from these nerve problems by following patients over 12 months in a prospective way, overcoming earlier studies' limitations related to short follow-up and small participant numbers. Participants will be recruited from hospitals, including neurology units and emergency departments, where they have been diagnosed with NOS-induced neurological damage by a neurologist. The study does not involve any treatment interventions but follows patients remotely through five scheduled assessments over 12 months. Data collected include neurological tests like finger tapping and cognitive function tasks, health questionnaires, and step counts. Initial hospital data such as MRI scans and blood tests will also be reviewed when available. The study uses a special platform to send participants links via text message for completing assessments remotely. Participants will be involved in five remote visits at baseline, 1 month, 3 months, 6 months, and 12 months, completing various questionnaires and tasks to monitor neurological recovery. The research team will track completed visits and send reminders as needed. A nested qualitative sub-study will interview some participants about their experiences with NOS, mental health, and treatment access. The main outcome measured is improvement in the finger tapping task over 12 months, along with cognitive function, physical activity, and neuropathy-related scales.

CONDITIONS

Brief Title

Neurological Recovery Following NOS-SACD

Who Can Participate

Age: 16Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient first presented with tingling, weakness, coordination problems, or walking difficulty and has a history of nitrous oxide use
  • Age between 16 and 40 years as of 19/08/2024
  • Able to read and write in English to complete questionnaires
  • Confirmed diagnosis of nitrous oxide-induced neurological damage by a consultant neurologist
Not Eligible

You will not qualify if you...

  • History of other causes of neuropathy or neurodegeneration
  • For the qualitative interview study, patients must be currently in the longitudinal study and report past or present mental health difficulties as per clinical history or PHQ-2 assessment
  • Patients who do not meet the inclusion criteria for the main study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or via telephone)

Baseline Assessment

Duration - At enrollment

Participants have their neurological assessment, MRI, blood tests, and concomitant medications reviewed, either in hospital or remotely. Initial questionnaires and cognitive tasks are completed.

1 baseline visit (in-person or remote)

Long-term Monitoring

Duration - 12 months

Participants complete remote follow-up assessments including cognitive tasks, health questionnaires, and activity monitoring over 12 months.

4 remote visits at 1 month, 3 months, 6 months, and 12 months

Trial Site Locations

Total: 3 locations

1

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Actively Recruiting

2

Barts Health NHS Trust

London, United Kingdom

Actively Recruiting

3

Salford Royal NHS Foundation Trust

Manchester, United Kingdom

Actively Recruiting

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Research Team

N

Nikos Evangelou, FRCP, DPhil

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Subacute combined degeneration of the spinal cord following nitrous oxide anesthesia: A systematic review of cases.

Kishan K Patel, Juan Carlos Mejia Munne, Vimal Raj Nitish Gunness...

https://pubmed.ncbi.nlm.nih.gov/30144777

Vitamin B12 extensive thoracic myelopathy: clinical, radiological and prognostic aspects. Two cases report and literature review.

Frederico Carvalho de Medeiros, Lucas Alverne Freitas de Albuquerque, Renata Brant de Souza...

https://pubmed.ncbi.nlm.nih.gov/23468407