Trigeminal NeuralgiaTRINCOSNCT04272385
Defining Core Outcome Sets in Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine what patients with trigeminal neuralgia (TN), clinicians and researchers in the field, consider to be the most important outcomes to be expected after undergoing treatment for trigeminal neuralgia and how this could be measured in all studies relating to this condition. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Observational
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2020to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been diagnosed with trigeminal neuralgia and are currently receiving treatment (medical or surgical). Clinicians and researchers working in the field.
Who may be able to join
- Adult patients (>18ys) diagnosed with trigeminal neuralgia
- Willing to attend a focus group meeting
- Able to give informed consent
- Undergoing management for trigeminal neuralgia
- Adult patients (>18ys) diagnosed with trigeminal neuralgia
- Clinicians working in the field of Trigeminal Neuralgia
Show all 16Show fewer
- Researchers working in the field of Trigeminal Neuralgia
- Willing to complete a 3 round Delphi survey
- Able to give informed consent
- Adult patients (>18ys) diagnosed with trigeminal neuralgia
- Clinicians working in the field of Trigeminal Neuralgia
- Researchers working in the field of Trigeminal Neuralgia
- Able to join an online meeting
- Have internet access
- Willing to participate in a discussion with others about the important treatment outcomes in Trigeminal Neuralgia
- Able to give informed consent
Who cannot join
- Unable to attend a focus group meeting
- Insufficient English to take part in a group discussion
- Unable to take part in discussions
Trial locations and contacts
1 site in 1 country.
Joanna Zakrzweska, Professor contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal National ENT and Eastman Dental Hospitals
London, WC1E 6DG
Carolina Venda Nova, carolina.venda-nova@nhs.net
About this study
The aim of this study is to determine what patients with trigeminal neuralgia (TN), clinicians and researchers in the field, consider to be the most important outcomes to be expected after undergoing treatment for trigeminal neuralgia and how this could be measured in all studies relating to this condition. This would enable different treatments to be compared using the same standards.
Read the detailed description
Trigeminal Neuralgia (TN) is a rare chronic condition that causes agonizing, unpredictable, short-lasting electric shock-like one-sided facial pain and is commonly provoked by triggers such as light touch. This debilitating chronic pain disorder has a significant impact on the quality of life of patients with increased risk of depression and suicide. The current varied outcome measures make it difficult for patients to make decisions about choice of treatments which was highlighted in a study among 156 United Kingdom (UK) patients with TN who completed an adapted time-trade - off utility measure to ascertain how they valued the potential outcomes from various surgical and medical treatments.
Patients can be managed with a range of anticonvulsants or by several types of neurosurgical interventions. To successfully compare the effectiveness and tolerability of various treatment options data is needed from well designed and conducted randomised controlled trials (RCTs) and prospective cohorts which use the same outcome measures. Apart from pain relief only a handful of other outcome measures have been used. It has to date not been possible to compare medical versus neurosurgical treatments and yet this is one of the most frequently asked patient questions. The impact of complications on ability to return to normal activities and improvement in mental health needs to be determined. The development and implementation of Core Outcome Sets (COS) and measures in clinical practice across the UK and in future trials would allow standardised outcome data, thereby facilitating meta-analysis and thus clinical decision-making.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Observational
- Keywords
- trigeminal neuralgia, treatment outcomes, patient reported outcome measures
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Qualitative research done with a group of patients with TN. Patients will describe their experience of living with the disease and what outcomes of treatment they consider to be important. Receives: Other: Observational | |
| Delphi survey | Group of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment in a 3 round Delphi survey. Receives: Other: Observational | |
| Consensus meeting | Group of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment and finalise the COS for Trigeminal Neuralgia. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the trigeminal neuralgia core outcome set
Measured: 2020-2022
Secondary outcomes (1)
Identify the instruments to use in the core outcome set
Measured: 2020-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start2 Mar 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Rosetrees Trust
- Responsible party
- Sponsor
- Investigators
- Joanna Zakrzweska, Professor, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272385
- Sponsor's protocol ID
- 17/0901
- Acronym
- TRINCOS
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Core Outcome Sets in Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT04272385
- Acronym / sponsor ID
- TRINCOS / 17/0901
- Conditions
- Trigeminal Neuralgia
- Keywords
- trigeminal neuralgia, treatment outcomes, patient reported outcome measures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Rosetrees Trust
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
The aim of this study is to determine what patients with trigeminal neuralgia (TN), clinicians and researchers in the field, consider to be the most important outcomes to be expected after undergoing treatment for trigeminal neuralgia and how this could be measured in all studies relating to this condition. This would enable different treatments to be compared using the same standards.
Detailed description
Trigeminal Neuralgia (TN) is a rare chronic condition that causes agonizing, unpredictable, short-lasting electric shock-like one-sided facial pain and is commonly provoked by triggers such as light touch. This debilitating chronic pain disorder has a significant impact on the quality of life of patients with increased risk of depression and suicide. The current varied outcome measures make it difficult for patients to make decisions about choice of treatments which was highlighted in a study among 156 United Kingdom (UK) patients with TN who completed an adapted time-trade - off utility measure to ascertain how they valued the potential outcomes from various surgical and medical treatments.
Patients can be managed with a range of anticonvulsants or by several types of neurosurgical interventions. To successfully compare the effectiveness and tolerability of various treatment options data is needed from well designed and conducted randomised controlled trials (RCTs) and prospective cohorts which use the same outcome measures. Apart from pain relief only a handful of other outcome measures have been used. It has to date not been possible to compare medical versus neurosurgical treatments and yet this is one of the most frequently asked patient questions. The impact of complications on ability to return to normal activities and improvement in mental health needs to be determined. The development and implementation of Core Outcome Sets (COS) and measures in clinical practice across the UK and in future trials would allow standardised outcome data, thereby facilitating meta-analysis and thus clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Other: ObservationalQualitative research done with a group of patients with TN. Patients will describe their experience of living with the disease and what outcomes of treatment they consider to be important. |
| Delphi survey | – | Other: ObservationalGroup of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment in a 3 round Delphi survey. |
| Consensus meeting | – | Other: ObservationalGroup of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment and finalise the COS for Trigeminal Neuralgia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been diagnosed with trigeminal neuralgia and are currently receiving treatment (medical or surgical). Clinicians and researchers working in the field.
Key inclusion criteria (16 listed)
- Adult patients (>18ys) diagnosed with trigeminal neuralgia
- Willing to attend a focus group meeting
- Able to give informed consent
- Undergoing management for trigeminal neuralgia
- Adult patients (>18ys) diagnosed with trigeminal neuralgia
Key exclusion criteria (3 listed)
- Unable to attend a focus group meeting
- Insufficient English to take part in a group discussion
- Unable to take part in discussions
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 |
|---|---|---|
| ObservationalObservational | Other | Consensus meeting, Delphi survey, Focus Group |
Primary outcome
Define the trigeminal neuralgia core outcome set
Time frame: 2020-2022
1 secondary outcome
Identify the instruments to use in the core outcome set
Time frame: 2020-2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Trigeminal Neuralgia
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 2
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
Trigeminal Neuralgia (TN)
RecruitingPhase 1/2
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cordor Placental Derived Stem Cells Exosomes for Trigeminal Neuralgia
Peripheral Neuropathy, Trigeminal Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
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. This study is not recruiting at the moment.
Joanna Zakrzweska, Professor contact
Joanna Zakrzweska, Professor principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by University College, London at 1 site 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 16 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Venda Nova, Ms (07587954704, carolina.venda-nova@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the trigeminal neuralgia core outcome set (time frame: 2020-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022; AzTrials last refreshed its copy on 30 Oct 2026.