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Neurological Recovery Following NOS-SACD

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated July 25, 2025 (before its estimated August 19, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary completion date: Mar 31, 2025 to Aug 19, 2026
    • Start date changed from estimate of Apr 1, 2023 to Aug 19, 2024
    • Study sites: 0 to 3
    • Study completion date: Jun 30, 2025 to Aug 19, 2026
    • Eligibility criteria expanded, about 26 words
    • Study description expanded, about 113 words
    • Collaborators: 5 to 3
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nitrous oxide has become an increasingly popular recreational drug amongst young people, particularly at festivals, nightclubs and parties. Considering the drug is not illegal to possess, has low cost in the form of 'whippets' and can be easily purchased online, it has become the second most commonly used recreational drug amongst people aged 16-24 in the UK. However, nitrous oxide is known to irreversibly inactivate the functioning of vitamin B12, a vitamin required for the maintenance and proper functioning of nerves in the spinal cord. Neurological symptoms in this population have been reported in around 3.4% of nitrous oxide users, although the true incidence is expected to be higher as the cases being reported by UK hospitals continues to rise. Patients may present with adverse neurological symptoms like tingling, weakness, coordination and mobility problems. Currently, studies reviewing the functional recovery of these patients have been limited by a retrospective study design, short follow up duration and being limited to small cohort sizes. This is in part linked to patient non-compliance and non-attendance at follow-up appointments. The investigators will therefore prospectively recruit all patients presenting with these symptoms and continue to collect data relating to their neurological recovery for 12 months. Data collection will be remote to ensure it is of low burden to the participants. This will allow the investigating team and others to fully appraise the severity of these toxic neuropathies and understand how best to manage their follow up.
Trial Details
NCT Number NCT05714917
Lead Sponsor Nottingham University Hospitals NHS Trust
Collaborators: Barts & The London NHS Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust
Conditions
(from sponsor)
Nitrous Oxide Abuse, Subacute Combined Cord Degeneration, Neurologic Symptoms, Paresthesia, B12 Deficiency Vitamin
Related terms Neurologic Manifestations, Paresthesia, Vitamin B 12 Deficiency
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov