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NCT Number: NCT07135024

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

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Facial Pain Glossopharyngeal Nerve Diseases Glossopharyngeal Neuralgia Hemifacial Spasm Mouth Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Neurovascular Conflict Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Stomatognathic Diseases Tic Douloureux Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University, Aachen, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • refusal of further use of routine clinical data

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Surgical complications

    Time frame: three months after index surgery

    any complications directly attributable to the surgical intervention

  2. Need for additional treatment

    Time frame: 5 years after index surgery

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

  3. Patient satisfaction

    Time frame: 5yrs after index surgery

    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.

  4. Effect of surgical treatment on quality of life

    Time frame: 5 years after index surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefanie Pflugi

CONTACT

[email protected]

+41628389203

Sponsors and collaborators

Lead sponsor

Gerrit A Schubert

Other

Collaborators

  • NeuroResearchOffice at Cantonal Hospital Aarau

Registry information

Acronym: PETER registry

Important dates

Study start
2025
Primary completion
2030
Study completion
2033
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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