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

NCT07135024 | Not Yet Recruiting

• 1 other identifier: PETER registry
• Study Type: observational
• Target: 5,001
• Locations: 2 countries
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrolment to last follow-up 5 yrs after surgery

Secondary Outcomes (4)

• Surgical complications

  three months after index surgery

• Need for additional treatment

  5 years after index surgery

• Patient satisfaction

  5yrs after index surgery

• Effect of surgical treatment on quality of life

  5 years after index surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• refusal of further use of routine clinical data

Sponsors & Collaborators

• Gerrit A Schubert: lead
• NeuroResearchOffice at Cantonal Hospital Aarau: collaborator

Study Sites (2)

Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Dept. of Neurosurgery, Cantonal Hospital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

MeSH Terms

Conditions

Trigeminal Neuralgia; Facial Pain; Glossopharyngeal Nerve Diseases; Hemifacial Spasm

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spasm; Neuromuscular Manifestations

Central Study Contacts

Stefanie Pflugi

CONTACT

+41628389203; nro@ksa.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Neurosurgery

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 21, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2033
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

DE (1); CH (1)