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

Active, not recruiting

• Conditions: Facial Pain

• Registration Number: NCT05147454
• Lead Sponsor: Walton Centre NHS Foundation Trust

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.

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 Timeline

• Study First Submitted: 2021-10-18
• Study Start: 2021-11-11
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-07
• Status Verified: 2024-07
• Primary Completion: 2024-07-17
• Study Completion: 2024-07-17
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensory Profile	Baseline, at the time of visit	Sensory Profile as assessed by Quantitative Sensory Testing

Secondary Outcome Measures

Name	Time	Method
Geometry of Neurovascular Compression	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)
Presence of Neurovascular Compression	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
Trigeminal Root Volume	Baseline, at the time of visit	Trigeminal Root Volume as assessed by specific neuroimaging Software (MIPAV)

Trial Locations

Locations (1)

The Walton Centre NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom