MRI & QST Analysis in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain

December 6, 2023 updated by: Walton Centre NHS Foundation Trust

Assessing Somatosensory System Damage in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain Through Neuroimaging and Quantitative Sensory Testing

Patients with a definite diagnosis of classical TGN and PIFP will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. Clinical measures and sensory profiles will be correlated with MRI measures.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with a definite diagnosis of classical TGN and PIFP (according to the 2020 ICOP Classification) will undergo a structured clinical questionnaire and a trigeminal sensory profile using the quantitative sensory testing. Clinical measures and sensory profiles will be correlated with the presence and the geometry of neurovascular compression at MRI. Moreover quantitative structural neuroimaging analysis, such as trigeminal root volume, will be performed in each patient and correlated with clinical and QST data.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L97AL
        • The Walton Centre NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients attending The Walton Centre Clinics

Description

Inclusion Criteria:

  • Definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia or Persistent Idiopathic Facial Pain according to the latest ICOP 2020 Criteria
  • Naive to any surgical procedures

Exclusion Criteria:

  • Any major chronic painful or other neurological disease
  • Diagnosis of Secondary Trigeminal Neuralgia
  • Diagnosis of other facial pain syndromes
  • Cognitive disturbances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trigeminal Neuralgia
Patients with a definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia
Other: Quantitative Sensory Testing
Non-invasive assessment of Sensory Profile
Persistent Idiopathic Facial Pain
Patients with a definite diagnosis of Persistent Idiopathic Facial Pain
Other: Quantitative Sensory Testing
Non-invasive assessment of Sensory Profile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Profile
Time Frame: Baseline, at the time of visit
Sensory Profile as assessed by Quantitative Sensory Testing
Baseline, at the time of visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Neurovascular Compression
Time Frame: Baseline, at the time of visit
Presence of Neurovascular Compression defined as absence of any liquor cleft between the trigeminal root and the offending vessel, on dedicated Trigeminal MRI
Baseline, at the time of visit
Trigeminal Root Volume
Time Frame: Baseline, at the time of visit
Trigeminal Root Volume as assessed by specific neuroimaging Software (MIPAV)
Baseline, at the time of visit
Geometry of Neurovascular Compression
Time Frame: Baseline, at the time of visit
Measurement of the polar coordinates beetween the trigeminal root and the offending vessel as assessed by specific neuroimaging Software (MIPAV)
Baseline, at the time of visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walton Centre NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Estimated)

May 17, 2024

Study Completion (Estimated)

May 17, 2024

Study Registration Dates

First Submitted

October 18, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG447-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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