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

N/ANot Yet RecruitingNCT07135024

Gerrit A Schubert5,001 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

5,001

Conditions

Trigeminal Neuralgia Tic Douloureux Facial Pain Glossopharyngeal Neuralgia Hemifacial Spasm Neurovascular Conflict

Outcomes

Primary Outcomes

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

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

Surgical complications

any complications directly attributable to the surgical intervention

Time frame: three months after index surgery

Need for additional treatment

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

Time frame: 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.

Time frame: 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.