Nitrous Oxide AbuseNCT05714917
Neurological Recovery Following NOS-SACD
An observational study of Nitrous Oxide Abuse and Subacute Combined Cord Degeneration, run by Nottingham University Hospitals NHS Trust at 3 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Nitrous Oxide Abuse, Subacute Combined Cord Degeneration, Neurologic Symptoms
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 19 Aug 2024to 19 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: NOS induced neurological symptoms may present with either a.) severe neurological impairment to warrant A\&E admission, or b.) milder symptoms which may present to primary care. The investigators team therefore propose recruitment pathways based either on A\&E or GP referral. Participants will be invited to the neurology team in order for them to coordinate the care according to local practices.
Who may be able to join
- 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.
Who cannot join
- •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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Dr Tom Hayton, N/K, tom.hayton@uhb.nhs.uk
- Recruiting
Barts Health NHS Trust
London
Prof Alastair Noyce, N/K, a.noyce@qmul.ac.uk
- Recruiting
Salford Royal NHS Foundation Trust
Manchester
Dr James Lilleker, N/K, james.lilleker@nca.nhs.uk
About this study
Official title: Longitudinal Assessment of Neurological Recovery in Patients Following Nitrous Oxide Abuse
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.
Read the detailed description
This study will take place in selected participating hospitals, including their acute neurology units and emergency departments. Participants presenting to their GP will be referred per standard clinical care with the acute neurology units for study inclusion review. Ideally in all cases the investigating team would prefer for participants to be in hospitals (either directly through A\&E or being referred by their GP to the acute neurology service) at the time of study inclusion and for the baseline visit to ensure standard clinical care data can be collected (including MRI, bloods and treatment information including how many Vitamin B12 injections are given at admission and throughout their recovery). Care will be taken over by the neurology team where possible and standard clinical practice for participants with NOS induced neurological damage will be managed and treated as per their own local guidelines. Patients identified to the research team with consultant confirmed NOS-induced neuropathy but have left hospital can still be considered for the study but oral consent will be asked of these participants.
Baseline visit: participants who remain in hospital at the time of study invite will have their concomitant medications, comorbidities and a neurological assessment reviewed in person, blood and MRI results will also be collected from the routine tests that have been performed whilst in hospital. Participants not in the hospital at this point will have this information assessed where possible via the telephone or obtained from their medical records. Individuals without blood or MRI data will not be excluded from the study providing they meet the inclusion criteria.
At the point of consent (written or verbal), recruited participants details (NHS number, name and mobile number) will be securely shared with the coordinating Nottingham University Hospitals NHS Trust center. The Nottingham researcher will then add new participants to the PsychoPy platform which is the University of Nottingham spinoff company that allows remote clinical trial assessments. Each time a participant is added, the platform will automatically generate follow up dates for when each of the subsequent visits are due (baseline visit, 1-month, 3- month, 6-month and 12-month). The Nottingham coordinating team will generate a specific link from this platform each time a participant visit is due, the link will then be sent via text messaging from the coordinating centre to the participants mobile phone. These links can be opened and the visits completed from anywhere provided the participant has internet connection. The content of the visits will include: demographic [baseline visit only], NOS quantification, basic finger tapping task, cognitive function tasks, health questionnaire assessing participants ability to perform simple daily activities, the overall neuropathy limitations scale and the average step count for the last 7-days.
The coordinating team will continue to monitor completed and outstanding visits for all participants and where uncompleted, will send out reminder text messages to the participants.
Our pragmatic approach to perform only remote follow ups was based on the already previously reported high DNA rate in this patient population. All patients will participate in a total of 5 remote visit assessments over the 12-month period.
A nested qualitative sub-study is being led by Professor Alastair Noyce and Dr Laura Smith, based at Queen Mary University of London. Semi-structured interviews will be undertaken with participants taking part in the longitudinal cohort study, who have agreed to be contacted about allied research opportunities. Interviews will cover their lived experiences of using NOS, any mental health difficulties experienced, and explore any links between these two areas. Participants will also be asked about any treatment accessed for NOS usage and mental health difficulties, and explore the barriers and facilitators to engagement with treatment. We will collect qualitative data at any point after the participant has provided informed consent for the qualitative sub-study.
- Conditions
- Nitrous Oxide Abuse, Subacute Combined Cord Degeneration, Neurologic Symptoms, Paresthesia, B12 Deficiency Vitamin
- Being tested
- Observational study with no interventions
- Keywords
- Nitrous oxide, B12, Neurological symptoms, Clinical recovery
- Medical subject headings
- Neurologic Manifestations, Paresthesia, Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study with no interventionsOther
Also called Observational Study
This is an observational study and there will be no clinical interventions.
| Study group | Role | What they receive |
|---|---|---|
| Confirmed diagnosis of NOS-induced neurological damage | 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. Receives: Other: Observational study with no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in finger tapping task, baseline to month 12
To determine whether patients with NOS-induced neurological damage recover their dexterity function over a 12-month period.
Measured: 12 months
Secondary outcomes (3)
Improvement in cognitive function task, baseline to month 12
To determine whether patients with NOS-induced neurological damage recover their cognitive function over a 12-month period.
Measured: 12 months
Improvement in step counts, baseline to month 12
To determine whether patients with NOS-induced neurological damage recover their average weekly step counts over a 12-month period.
Measured: 12 months
Improvement in I-RODS and ONLS, baseline to month 12
To determine whether patients with NOS-induced neurological damage recover their neuropathy and general health scores over a 12-month period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start19 Aug 2024
- Primary completion19 Aug 2026 (estimated)
- Study completion19 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Nitrous Oxide AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714917
- Sponsor's protocol ID
- 22NS021
- Status last verified
- Jul 2025
- First submitted
- 18 Jan 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team have not yet established a plan to share IPD.
Publications
Kroes AC, Lindemans J, Abels J. [Interaction between nitrous oxide and vitamin B12]. Ned Tijdschr Geneeskd. 1985 Nov 23;129(47):2243-7. No abstract available. Dutch.
PubMed 4088327Omotosho YB, Ying GW, Orji R, Patel H. Recreational Nitrous Oxide-Induced Subacute Combined Degeneration. Cureus. 2022 Mar 22;14(3):e23409. doi: 10.7759/cureus.23409. eCollection 2022 Mar.
PubMed 35475085Winstock AR, Ferris JA. Nitrous oxide causes peripheral neuropathy in a dose dependent manner among recreational users. J Psychopharmacol. 2020 Feb;34(2):229-236. doi: 10.1177/0269881119882532. Epub 2019 Nov 4.
PubMed 31679459Schilling RF. Is nitrous oxide a dangerous anesthetic for vitamin B12-deficient subjects? JAMA. 1986 Mar 28;255(12):1605-6.
PubMed 3951096Flippo TS, Holder WD Jr. Neurologic degeneration associated with nitrous oxide anesthesia in patients with vitamin B12 deficiency. Arch Surg. 1993 Dec;128(12):1391-5. doi: 10.1001/archsurg.1993.01420240099018.
PubMed 8250714Patel KK, Mejia Munne JC, Gunness VRN, Hersey D, Alshafai N, Sciubba D, Nasser R, Gimbel D, Cheng J, Nouri A. Subacute combined degeneration of the spinal cord following nitrous oxide anesthesia: A systematic review of cases. Clin Neurol Neurosurg. 2018 Oct;173:163-168. doi: 10.1016/j.clineuro.2018.08.016. Epub 2018 Aug 9.
PubMed 30144777Seed A, Jogia M. Lessons of the month: Nitrous oxide-induced functional vitamin B12 deficiency causing subacute combined degeneration of the spinal cord. Clin Med (Lond). 2020 May;20(3):e7-e9. doi: 10.7861/clinmed.2020-0072.
PubMed 32414730de Medeiros FC, de Albuquerque LA, de Souza RB, Gomes Neto AP, Christo PP. Vitamin B12 extensive thoracic myelopathy: clinical, radiological and prognostic aspects. Two cases report and literature review. Neurol Sci. 2013 Oct;34(10):1857-60. doi: 10.1007/s10072-013-1335-7. Epub 2013 Mar 7.
PubMed 23468407Algahtani H, Shirah B, Abdelghaffar N, Abuhawi O, Alqahtani A. Nitrous oxide recreational abuse presenting with myeloneuropathy and mimicking Guillain-Barre syndrome. Intractable Rare Dis Res. 2020 Feb;9(1):54-57. doi: 10.5582/irdr.2020.01007.
PubMed 32201677Swart G, Blair C, Lu Z, Yogendran S, Offord J, Sutherland E, Barnes S, Palavra N, Cremer P, Bolitho S, Michael Halmagyi G. Nitrous oxide-induced myeloneuropathy. Eur J Neurol. 2021 Dec;28(12):3938-3944. doi: 10.1111/ene.15077. Epub 2021 Sep 6.
PubMed 34427020Berling E, Fargeot G, Aure K, Tran TH, Kubis N, Lozeron P, Zanin A. Nitrous oxide-induced predominantly motor neuropathies: a follow-up study. J Neurol. 2022 May;269(5):2720-2726. doi: 10.1007/s00415-021-10858-2. Epub 2021 Nov 6.
PubMed 34741241Garakani A, Jaffe RJ, Savla D, Welch AK, Protin CA, Bryson EO, McDowell DM. Neurologic, psychiatric, and other medical manifestations of nitrous oxide abuse: A systematic review of the case literature. Am J Addict. 2016 Aug;25(5):358-69. doi: 10.1111/ajad.12372. Epub 2016 Apr 1.
PubMed 27037733Zheng D, Ba F, Bi G, Guo Y, Gao Y, Li W. The sharp rise of neurological disorders associated with recreational nitrous oxide use in China: a single-center experience and a brief review of Chinese literature. J Neurol. 2020 Feb;267(2):422-429. doi: 10.1007/s00415-019-09600-w. Epub 2019 Oct 26.
PubMed 31655888Peirce J, Gray JR, Simpson S, MacAskill M, Hochenberger R, Sogo H, Kastman E, Lindelov JK. PsychoPy2: Experiments in behavior made easy. Behav Res Methods. 2019 Feb;51(1):195-203. doi: 10.3758/s13428-018-01193-y.
PubMed 30734206Hibbert A, Hashi M, Symes I, Hayton T, Lilleker JB, Dodd K, Evangelou N, Noyce AJ, Smith LJ. Inclusive approaches to research and healthcare for nitrous oxide users: lessons from a longitudinal study. BMJ Neurol Open. 2026 Apr 9;8(1):e001522. doi: 10.1136/bmjno-2025-001522. eCollection 2026.
PubMed 42007399
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Neurological Recovery in Patients Following Nitrous Oxide Abuse
- ClinicalTrials.gov ID
- NCT05714917
- Acronym / sponsor ID
- 22NS021
- Conditions
- Nitrous Oxide Abuse, Subacute Combined Cord Degeneration, Neurologic Symptoms, Paresthesia, B12 Deficiency Vitamin
- Keywords
- Nitrous oxide, B12, Neurological symptoms, Clinical recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, Northern Care Alliance NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 19 Aug 2026 (estimated)
- Study completion
- 19 Aug 2026 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will take place in selected participating hospitals, including their acute neurology units and emergency departments. Participants presenting to their GP will be referred per standard clinical care with the acute neurology units for study inclusion review. Ideally in all cases the investigating team would prefer for participants to be in hospitals (either directly through A\&E or being referred by their GP to the acute neurology service) at the time of study inclusion and for the baseline visit to ensure standard clinical care data can be collected (including MRI, bloods and treatment information including how many Vitamin B12 injections are given at admission and throughout their recovery). Care will be taken over by the neurology team where possible and standard clinical practice for participants with NOS induced neurological damage will be managed and treated as per their own local guidelines. Patients identified to the research team with consultant confirmed NOS-induced neuropathy but have left hospital can still be considered for the study but oral consent will be asked of these participants.
Baseline visit: participants who remain in hospital at the time of study invite will have their concomitant medications, comorbidities and a neurological assessment reviewed in person, blood and MRI results will also be collected from the routine tests that have been performed whilst in hospital. Participants not in the hospital at this point will have this information assessed where possible via the telephone or obtained from their medical records. Individuals without blood or MRI data will not be excluded from the study providing they meet the inclusion criteria.
At the point of consent (written or verbal), recruited participants details (NHS number, name and mobile number) will be securely shared with the coordinating Nottingham University Hospitals NHS Trust center. The Nottingham researcher will then add new participants to the PsychoPy platform which is the University of Nottingham spinoff company that allows remote clinical trial assessments. Each time a participant is added, the platform will automatically generate follow up dates for when each of the subsequent visits are due (baseline visit, 1-month, 3- month, 6-month and 12-month). The Nottingham coordinating team will generate a specific link from this platform each time a participant visit is due, the link will then be sent via text messaging from the coordinating centre to the participants mobile phone. These links can be opened and the visits completed from anywhere provided the participant has internet connection. The content of the visits will include: demographic [baseline visit only], NOS quantification, basic finger tapping task, cognitive function tasks, health questionnaire assessing participants ability to perform simple daily activities, the overall neuropathy limitations scale and the average step count for the last 7-days.
The coordinating team will continue to monitor completed and outstanding visits for all participants and where uncompleted, will send out reminder text messages to the participants.
Our pragmatic approach to perform only remote follow ups was based on the already previously reported high DNA rate in this patient population. All patients will participate in a total of 5 remote visit assessments over the 12-month period.
A nested qualitative sub-study is being led by Professor Alastair Noyce and Dr Laura Smith, based at Queen Mary University of London. Semi-structured interviews will be undertaken with participants taking part in the longitudinal cohort study, who have agreed to be contacted about allied research opportunities. Interviews will cover their lived experiences of using NOS, any mental health difficulties experienced, and explore any links between these two areas. Participants will also be asked about any treatment accessed for NOS usage and mental health difficulties, and explore the barriers and facilitators to engagement with treatment. We will collect qualitative data at any point after the participant has provided informed consent for the qualitative sub-study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed diagnosis of NOS-induced neurological damage | – | Other: Observational study with no interventionsAny 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. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- NOS induced neurological symptoms may present with either a.) severe neurological impairment to warrant A\&E admission, or b.) milder symptoms which may present to primary care. The investigators team therefore propose recruitment pathways based either on A\&E or GP referral. Participants will be invited to the neurology team in order for them to coordinate the care according to local practices.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- •Other causes of previous neuropathy or neurodegeneration indicated.
- Patients currently taking part in the longitudinal study.
- Patients who report previously (clinical history) or currently (PHQ-2, clinical history) experiencing mental health difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study with no interventionsAlso: Observational StudyThis is an observational study and there will be no clinical interventions. | Other | Confirmed diagnosis of NOS-induced neurological damage |
Primary outcome
Improvement in finger tapping task, baseline to month 12
Time frame: 12 months
To determine whether patients with NOS-induced neurological damage recover their dexterity function over a 12-month period.
3 secondary outcomes
Improvement in cognitive function task, baseline to month 12
Time frame: 12 months
Improvement in step counts, baseline to month 12
Time frame: 12 months
Improvement in I-RODS and ONLS, baseline to month 12
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 4088327Kroes AC, Lindemans J, Abels J. [Interaction between nitrous oxide and vitamin B12]. Ned Tijdschr Geneeskd. 1985 Nov 23;129(47):2243-7. No abstract available. Dutch.
- Background: PubMed 35475085Omotosho YB, Ying GW, Orji R, Patel H. Recreational Nitrous Oxide-Induced Subacute Combined Degeneration. Cureus. 2022 Mar 22;14(3):e23409. doi: 10.7759/cureus.23409. eCollection 2022 Mar.
- Background: PubMed 31679459Winstock AR, Ferris JA. Nitrous oxide causes peripheral neuropathy in a dose dependent manner among recreational users. J Psychopharmacol. 2020 Feb;34(2):229-236. doi: 10.1177/0269881119882532. Epub 2019 Nov 4.
- Background: PubMed 3951096Schilling RF. Is nitrous oxide a dangerous anesthetic for vitamin B12-deficient subjects? JAMA. 1986 Mar 28;255(12):1605-6.
- Background: PubMed 8250714Flippo TS, Holder WD Jr. Neurologic degeneration associated with nitrous oxide anesthesia in patients with vitamin B12 deficiency. Arch Surg. 1993 Dec;128(12):1391-5. doi: 10.1001/archsurg.1993.01420240099018.
- Background: PubMed 30144777Patel KK, Mejia Munne JC, Gunness VRN, Hersey D, Alshafai N, Sciubba D, Nasser R, Gimbel D, Cheng J, Nouri A. Subacute combined degeneration of the spinal cord following nitrous oxide anesthesia: A systematic review of cases. Clin Neurol Neurosurg. 2018 Oct;173:163-168. doi: 10.1016/j.clineuro.2018.08.016. Epub 2018 Aug 9.
- Background: PubMed 32414730Seed A, Jogia M. Lessons of the month: Nitrous oxide-induced functional vitamin B12 deficiency causing subacute combined degeneration of the spinal cord. Clin Med (Lond). 2020 May;20(3):e7-e9. doi: 10.7861/clinmed.2020-0072.
- Background: PubMed 23468407de Medeiros FC, de Albuquerque LA, de Souza RB, Gomes Neto AP, Christo PP. Vitamin B12 extensive thoracic myelopathy: clinical, radiological and prognostic aspects. Two cases report and literature review. Neurol Sci. 2013 Oct;34(10):1857-60. doi: 10.1007/s10072-013-1335-7. Epub 2013 Mar 7.
- Background: PubMed 32201677Algahtani H, Shirah B, Abdelghaffar N, Abuhawi O, Alqahtani A. Nitrous oxide recreational abuse presenting with myeloneuropathy and mimicking Guillain-Barre syndrome. Intractable Rare Dis Res. 2020 Feb;9(1):54-57. doi: 10.5582/irdr.2020.01007.
- Background: PubMed 34427020Swart G, Blair C, Lu Z, Yogendran S, Offord J, Sutherland E, Barnes S, Palavra N, Cremer P, Bolitho S, Michael Halmagyi G. Nitrous oxide-induced myeloneuropathy. Eur J Neurol. 2021 Dec;28(12):3938-3944. doi: 10.1111/ene.15077. Epub 2021 Sep 6.
- Background: PubMed 34741241Berling E, Fargeot G, Aure K, Tran TH, Kubis N, Lozeron P, Zanin A. Nitrous oxide-induced predominantly motor neuropathies: a follow-up study. J Neurol. 2022 May;269(5):2720-2726. doi: 10.1007/s00415-021-10858-2. Epub 2021 Nov 6.
- Background: PubMed 27037733Garakani A, Jaffe RJ, Savla D, Welch AK, Protin CA, Bryson EO, McDowell DM. Neurologic, psychiatric, and other medical manifestations of nitrous oxide abuse: A systematic review of the case literature. Am J Addict. 2016 Aug;25(5):358-69. doi: 10.1111/ajad.12372. Epub 2016 Apr 1.
- Drug misuse in England and Wales - Office for National StatisticsLink provided by the sponsor.
- Global Drug Survey 2021Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The study team have not yet established a plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nitrous Oxide Abuse and Subacute Combined Cord Degeneration, run by Nottingham University Hospitals NHS Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikos Evangelou, FRCP, DPhil (07715172966, nikos.evangelou@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in finger tapping task, baseline to month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714917, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.