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NCT05147454 Clinical Trial

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

Facial Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05147454
Other study ID # RG447-21
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 11, 2021
Est. completion date May 17, 2024

Study information
Verified date December 2023
Source Walton Centre NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date May 17, 2024
Est. primary completion date May 17, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Quantitative Sensory Testing
Non-invasive assessment of Sensory Profile

Locations
Country Name City State
United Kingdom The Walton Centre NHS Foundation Trust Liverpool

Sponsors (1)
Lead Sponsor Collaborator
Walton Centre NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensory Profile Sensory Profile as assessed by Quantitative Sensory Testing Baseline, at the time of visit
Secondary Presence of Neurovascular Compression 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
Secondary Trigeminal Root Volume Trigeminal Root Volume as assessed by specific neuroimaging Software (MIPAV) Baseline, at the time of visit
Secondary Geometry of Neurovascular Compression 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
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