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Not yet recruitingNCT07135024PETER registryUpdated Aug 21, 2025

Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict

An observational study in Trigeminal Neuralgia, Tic Douloureux and Facial Pain, sponsored by Gerrit A Schubert. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by Gerrit A Schubert · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,001
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • 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
03

In context

Trigeminal Neuralgia

140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

This study's planned enrollment of 5,001 is above the median of 84 across 38 observational studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

This is the only study on the registry with Gerrit A Schubert as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study cohort will be selected from local Department of Neurosurgery of participating hospitals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • suspected neurovascular conflict
  • signed consent for further use of routine clinical data as accepted by local regulations

Exclusion criteria

Exclusion Criteria:

  • refusal of further use of routine clinical data
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,001 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrolment to last follow-up 5 yrs after surgery

  2. 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.

    Time frame: From enrolment to last follow-up 5 yrs after surgery

Secondary outcomes

  1. Surgical complications

    any complications directly attributable to the surgical intervention

    Time frame: three months after index surgery

  2. Need for additional treatment

    rate of patients having to undergo additional surgery / intervention / medication after microvascular decompression

    Time frame: 5 years after index surgery

  3. 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.

    Time frame: 5yrs after index surgery

  4. 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.

    Time frame: 5 years after index surgery

07

Study locations

2 sites
  • Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University
    Aachen, North Rhine-Westphalia 52074, Germany
  • Dept. of Neurosurgery, Cantonal Hospital Aarau
    Aarau, Canton of Aargau 5001, Switzerland
    • Stefanie Pflugi, PhD · Contactstefanie.pflugi@ksa.ch · +41 62 838 2778
    • Gerrit A Schubert, MD · Principal investigator
    • Debora Cipriani, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2025; primary completion for Oct 2030, 60 months later.

Of 19 observational studies under Trigeminal Neuralgia, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2025
First posted
Aug 21, 2025
StartEst.
Oct 1, 2025
Primary completionEst.
Oct 1, 2030
CompletionEst.
Oct 1, 2033
Last update
Aug 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07135024
Lead sponsor
Gerrit A Schubert
Collaborators
NeuroResearchOffice at Cantonal Hospital Aarau
Responsible party
Gerrit A Schubert (Head of Neurosurgery, Kantonsspital Aarau) — Sponsor-investigator
First posted
Aug 21, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 1, 2030 (estimated)
Completion
Oct 1, 2033 (estimated)
Last update
Aug 21, 2025

Study contacts

Stefanie Pflugi
Contact
nro@ksa.ch
+41628389203

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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