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OpenTrials
Active, Not Recruiting

NCT Number: NCT05147454

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Walton Centre NHS Foundation Trust

Liverpool, L97AL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative Sensory Testing

Other

Non-invasive assessment of Sensory Profile

Primary outcomes

  1. Sensory Profile

    Time frame: Baseline, at the time of visit

    Sensory Profile as assessed by Quantitative Sensory Testing

Secondary outcomes

  1. 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

  2. Trigeminal Root Volume

    Time frame: Baseline, at the time of visit

    Trigeminal Root Volume as assessed by specific neuroimaging Software (MIPAV)

  3. 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)

Sponsors and collaborators

Lead sponsor

Walton Centre NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2021
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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