Facial PainNCT05147454
MRI & QST Analysis in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain
An observational study of Facial Pain, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Pain
- What is being tested?
- Quantitative Sensory Testing
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2021to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients attending The Walton Centre Clinics
Who may be able to join
- 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
Who cannot join
- Any major chronic painful or other neurological disease
- Diagnosis of Secondary Trigeminal Neuralgia
- Diagnosis of other facial pain syndromes
- Cognitive disturbances
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, L97AL
About this study
Official title: Assessing Somatosensory System Damage in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain Through Neuroimaging and Quantitative Sensory Testing
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.
Read the 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.
- Conditions
- Facial Pain
- Being tested
- Quantitative Sensory Testing
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestingOther
Non-invasive assessment of Sensory Profile
| Study group | Role | What they receive |
|---|---|---|
| Trigeminal Neuralgia | Patients with a definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia Receives: Other: Quantitative Sensory Testing | |
| Persistent Idiopathic Facial Pain | Patients with a definite diagnosis of Persistent Idiopathic Facial Pain Receives: Other: Quantitative Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Profile
Sensory Profile as assessed by Quantitative Sensory Testing
Measured: Baseline, at the time of visit
Secondary outcomes (3)
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
Measured: Baseline, at the time of visit
Trigeminal Root Volume
Trigeminal Root Volume as assessed by specific neuroimaging Software (MIPAV)
Measured: Baseline, at the time of visit
Geometry of Neurovascular Compression
Measurement of the polar coordinates beetween the trigeminal root and the offending vessel as assessed by specific neuroimaging Software (MIPAV)
Measured: Baseline, at the time of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start11 Nov 2021
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147454
- Sponsor's protocol ID
- RG447-21
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Somatosensory System Damage in Trigeminal Neuralgia and Persistent Idiopathic Facial Pain Through Neuroimaging and Quantitative Sensory Testing
- ClinicalTrials.gov ID
- NCT05147454
- Acronym / sponsor ID
- RG447-21
- Conditions
- Facial Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trigeminal Neuralgia | – | Other: Quantitative Sensory TestingPatients with a definite diagnosis of Classical or Idiopathic Trigeminal Neuralgia |
| Persistent Idiopathic Facial Pain | – | Other: Quantitative Sensory TestingPatients with a definite diagnosis of Persistent Idiopathic Facial Pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients attending The Walton Centre Clinics
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Any major chronic painful or other neurological disease
- Diagnosis of Secondary Trigeminal Neuralgia
- Diagnosis of other facial pain syndromes
- Cognitive disturbances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory TestingNon-invasive assessment of Sensory Profile | Other | Persistent Idiopathic Facial Pain, Trigeminal Neuralgia |
Primary outcome
Sensory Profile
Time frame: Baseline, at the time of visit
Sensory Profile as assessed by Quantitative Sensory Testing
3 secondary outcomes
Presence of Neurovascular Compression
Time frame: Baseline, at the time of visit
Trigeminal Root Volume
Time frame: Baseline, at the time of visit
Geometry of Neurovascular Compression
Time frame: Baseline, at the time of visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Pain, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Profile (time frame: Baseline, at the time of visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.