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

Not yet recruiting

• Conditions: Tic Douloureux; Trigeminal Neuralgia; Facial Pain; Glossopharyngeal Neuralgia; Hemifacial Spasm; Neurovascular Conflict

• Registration Number: NCT07135024
• Lead Sponsor: Gerrit A Schubert

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-10-01
• Primary Completion: 2030-10-01
• Study Completion: 2033-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5001

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Face specific pain relief after surgical treatment	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.
Pain relief after surgical treatment	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	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.
Effect of surgical treatment on quality of life	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.
Surgical complications	three months after index surgery	any complications directly attributable to the surgical intervention
Need for additional treatment	5 years after index surgery	rate of patients having to undergo additional surgery / intervention / medication after microvascular decompression

Trial Locations

Locations (2)

Dept. of Neurosurgery, RWTH Aachen University Hospital, RWTH Aachen University; 🇩🇪 Aachen, NRW, Germany

Dept. of Neurosurgery, Cantonal Hospital Aarau; 🇨🇭 Aarau, Aargau, Switzerland