MRI & QST Analysis in Trigeminal Neuralgia and Persistent... | NCT05147454

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

NCT05147454

Sponsor

Walton Centre NHS Foundation Trust

Status

Active, not recruiting

Last Update Posted

Jul 24, 2024Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Facial Pain

Interventions

Quantitative Sensory Testing

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2021Actual

Primary Completion Date

Jul 17, 2024Estimated

Completion Date

Jul 17, 2024Estimated

First Submitted Date

Oct 18, 2021

First Submission Date that Met QC Criteria

Nov 23, 2021

First Posted Date

Dec 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2024

Last Update Posted Date

Jul 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Quantitative Sensory Testing	Other	Non-invasive assessment of Sensory Profile	Persistent Idiopathic Facial Pain Trigeminal Neuralgia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensory Profile	Sensory Profile as assessed by Quantitative Sensory Testing	Baseline, at the time of visit

Secondary Outcomes

Measure	Description	Time Frame
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
Trigeminal Root Volume

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients attending The Walton Centre Clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Walton Centre NHS Foundation Trust		Liverpool		L97AL	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D005157	Facial Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided