Trigeminal NeuralgiaPETER registryNCT07135024
Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
An observational study of Trigeminal Neuralgia and Tic Douloureux, run by Gerrit A Schubert at 2 sites in 2 countries.
Trial summary
The aim of the registry is a multicenter, prospective long-term data collection of patients suspected neurovascular conflict and referred for possible microvascular decompression (Jannetta procedure). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Tic Douloureux, Facial Pain
- How many people
- 5,001 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2025to 1 Oct 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study cohort will be selected from local Department of Neurosurgery of participating hospitals
Who may be able to join
- suspected neurovascular conflict
- signed consent for further use of routine clinical data as accepted by local regulations
Who cannot join
- refusal of further use of routine clinical data
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University
Aachen, North Rhine-Westphalia, 52074
Hans Clusmann, Univ.-Prof. Dr. med., +49 241 8088481, hclusmann@ukaachen.de
Switzerland1 site
Dept. of Neurosurgery, Cantonal Hospital Aarau
Aarau, Canton of Aargau, 5001
Stefanie Pflugi, PhD, +41 62 838 2778, stefanie.pflugi@ksa.ch
Gerrit A Schubert, MD
About this study
The aim of the registry is a multicenter, prospective long-term data collection of patients suspected neurovascular conflict and referred for possible microvascular decompression (Jannetta procedure). The registry relies exclusively on routinely collected clinical data, which are gathered in a standardized and privacy-compliant manner as part of everyday clinical practice. By systematically compiling this information across multiple centers, valuable insights into the effectiveness, potential side effects, and long-term outcomes of this surgical treatment can be gained. The registry will serve as a foundation for future scientific analyses and is intended to help answer relevant research questions regarding the treatment of trigeminal neuralgia based on solid evidence.
- Conditions
- Trigeminal Neuralgia, Tic Douloureux, Facial Pain, Glossopharyngeal Neuralgia, Hemifacial Spasm, Neurovascular Conflict
- Keywords
- Trigeminal Neuralgia, Registry, prospective study, eligibility determination, efficacy, treatment, Follow-Up Studies, indication, microvascular decompression, Jannetta, tic douloureux, hemifacial spasm, neurovascular conflict, glossopharyngeal neuralgia
- Medical subject headings
- Trigeminal Neuralgia, Facial Pain, Glossopharyngeal Nerve Diseases, Hemifacial Spasm
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief after surgical treatment
Efficacy of microvascular decompression surgery, defined by the change in pain as assessed by the patient using the Visual Analog Scale (VAS) from 0 to 100 mm, with higher scores representing worse outcomes.
Measured: From enrolment to last follow-up 5 yrs after surgery
Face specific pain relief after surgical treatment
Efficacy of microvascular decompression surgery, defined by the change in facial pain and pain interference as assessed by the patient using the Brief Pain Inventory-Facial (BPI-Facial), with numerical scores ranging from 0 to 10, where higher scores represent worse outcomes.
Measured: From enrolment to last follow-up 5 yrs after surgery
Secondary outcomes (4)
Surgical complications
any complications directly attributable to the surgical intervention
Measured: three months after index surgery
Need for additional treatment
rate of patients having to undergo additional surgery / intervention / medication after microvascular decompression
Measured: 5 years after index surgery
Patient satisfaction
Perceived benefit of surgery as determined by Patient global impression of change (PGIC) scores. The PGIC is a 7-point, patient-reported scale that captures an individual's overall perception of change in their condition. It ranges from "very much improved" to "very much worse," enabling patients to rate whether they feel their health has improved, remained the same, or declined.
Measured: 5yrs after index surgery
Effect of surgical treatment on quality of life
Efficacy of microvascular decompression surgery as defined by change of Quality of Life Questionaire as measured by EQ-5D-5L. The EQ-5D-5L is a standardized, patient-reported outcome measure that assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from "no problems" to "extreme problems.
Measured: 5 years after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,001 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gerrit A Schubert
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroResearchOffice at Cantonal Hospital Aarau
- Responsible party
- Sponsor-investigator, Gerrit A Schubert, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135024
- Sponsor's protocol ID
- PETER registry
- Acronym
- PETER registry
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
- ClinicalTrials.gov ID
- NCT07135024
- Acronym / sponsor ID
- PETER registry / PETER registry
- Conditions
- Trigeminal Neuralgia, Tic Douloureux, Facial Pain, Glossopharyngeal Neuralgia, Hemifacial Spasm, Neurovascular Conflict
- Keywords
- Trigeminal Neuralgia, Registry, prospective study, eligibility determination, efficacy, treatment, Follow-Up Studies, indication, microvascular decompression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,001 participants (estimated)
- Lead sponsor
- Gerrit A SchubertUniversity, hospital or other
- Collaborators
- NeuroResearchOffice at Cantonal Hospital Aarau
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2033 (estimated)
- First posted
- 21 Aug 2025 (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.
The aim of the registry is a multicenter, prospective long-term data collection of patients suspected neurovascular conflict and referred for possible microvascular decompression (Jannetta procedure). The registry relies exclusively on routinely collected clinical data, which are gathered in a standardized and privacy-compliant manner as part of everyday clinical practice. By systematically compiling this information across multiple centers, valuable insights into the effectiveness, potential side effects, and long-term outcomes of this surgical treatment can be gained. The registry will serve as a foundation for future scientific analyses and is intended to help answer relevant research questions regarding the treatment of trigeminal neuralgia based on solid evidence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study cohort will be selected from local Department of Neurosurgery of participating hospitals
Key inclusion criteria (2 listed)
- suspected neurovascular conflict
- signed consent for further use of routine clinical data as accepted by local regulations
Key exclusion criteria (1 listed)
- refusal of further use of routine clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain relief after surgical treatment
Time frame: From enrolment to last follow-up 5 yrs after surgery
Efficacy of microvascular decompression surgery, defined by the change in pain as assessed by the patient using the Visual Analog Scale (VAS) from 0 to 100 mm, with higher scores representing worse outcomes.
Face specific pain relief after surgical treatment
Time frame: From enrolment to last follow-up 5 yrs after surgery
Efficacy of microvascular decompression surgery, defined by the change in facial pain and pain interference as assessed by the patient using the Brief Pain Inventory-Facial (BPI-Facial), with numerical scores ranging from 0 to 10, where higher scores represent worse outcomes.
4 secondary outcomes
Surgical complications
Time frame: three months after index surgery
Need for additional treatment
Time frame: 5 years after index surgery
Patient satisfaction
Time frame: 5yrs after index surgery
Effect of surgical treatment on quality of life
Time frame: 5 years after index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia and Tic Douloureux, run by Gerrit A Schubert at 2 sites in 2 countries.
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 1 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Pflugi (+41628389203, nro@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief after surgical treatment (time frame: From enrolment to last follow-up 5 yrs after surgery). The study lists 2 primary outcomes in all. 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 21 Aug 2025.