NCT05147454

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 18, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

October 18, 2021

Last Update Submit

July 23, 2024

Conditions

Facial Pain

Outcome Measures

Primary Outcomes (1)

  • Sensory Profile

    Sensory Profile as assessed by Quantitative Sensory Testing

    Baseline, at the time of visit

Secondary Outcomes (3)

  • Presence of Neurovascular Compression

    Baseline, at the time of visit

  • Trigeminal Root Volume

    Baseline, at the time of visit

  • Geometry of Neurovascular Compression

    Baseline, at the time of visit

Study Arms (2)

Trigeminal Neuralgia

Patients with a definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia

Other: Quantitative Sensory Testing

Persistent Idiopathic Facial Pain

Patients with a definite diagnosis of Persistent Idiopathic Facial Pain

Other: Quantitative Sensory Testing

Interventions

Quantitative Sensory TestingOTHER

Non-invasive assessment of Sensory Profile

Persistent Idiopathic Facial PainTrigeminal Neuralgia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients attending The Walton Centre Clinics

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, L97AL, United Kingdom

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

October 18, 2021

First Posted

December 7, 2021

Study Start

November 11, 2021

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations

GB(1)