NCT04272385

Brief 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. This would enable different treatments to be compared using the same standards.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

2.5 years

First QC Date

February 13, 2020

Last Update Submit

February 3, 2022

Conditions

Trigeminal Neuralgia

Keywords

trigeminal neuralgiatreatment outcomespatient reported outcome measures

Outcome Measures

Primary Outcomes (1)

  • Define the trigeminal neuralgia core outcome set

    2020-2022

Secondary Outcomes (1)

  • Identify the instruments to use in the core outcome set

    2020-2022

Study Arms (3)

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.

Other: Observational

Delphi survey

Group of relevant stakeholders - patients, clinicians and researchers will rate the outcomes of treatment in a 3 round Delphi survey.

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.

Other: Observational

Interventions

ObservationalOTHER

Observational

Consensus meetingDelphi surveyFocus Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adult patients (\>18ys) diagnosed with trigeminal neuralgia
  • Willing to attend a focus group meeting
  • Able to give informed consent
  • Undergoing management for trigeminal neuralgia

You may not qualify if:

  • Unable to attend a focus group meeting
  • Insufficient English to take part in a group discussion
  • Unable to take part in discussions
  • Adult patients (\>18ys) diagnosed with trigeminal neuralgia
  • Clinicians working in the field of Trigeminal Neuralgia
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal National ENT and Eastman Dental Hospitals

London, WC1E 6DG, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Joanna Zakrzweska, Professor

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Venda Nova, Ms

CONTACT

07587954704carolina.venda-nova@nhs.net

Joanna Zakrzweska, Professor

CONTACT

j.zakrzewska@ucl.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2020

First Posted

February 17, 2020

Study Start

March 2, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)