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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05147454
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : December 7, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Facial Pain Other: Quantitative Sensory Testing

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Assessing Somatosensory System Damage in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain Through Neuroimaging and Quantitative Sensory Testing
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sensory Profile [ Time Frame: Baseline, at the time of visit ]
    Sensory Profile as assessed by Quantitative Sensory Testing


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients attending The Walton Centre Clinics
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147454


Contacts
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Contact: Gianfranco De Stefano 01515295835 Gianfranco.DeStefano@thewaltoncentre.nhs.uk
Contact: Bernhard Frank Bernhard.Frank@thewaltoncentre.nhs.uk

Locations
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United Kingdom
The Walton Centre NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L97AL
Contact: Gianfranco De Stefano    01515285835    Gianfranco.DeStefano@thewaltoncentre.nhs.uk   
Contact: Bernhard Frank       Bernhard.Frank@thewaltoncentr.nhs.uk   
Sponsors and Collaborators
Walton Centre NHS Foundation Trust
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Responsible Party: Walton Centre NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05147454    
Other Study ID Numbers: RG447-21
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Facies
Facial Pain
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases