Data Collection and Analysis in Brainstem Surgeries

Recruiting

• Conditions: Brainstem Lesion; Surgery; Intraoperative Neurophysiologic Monitoring

• Registration Number: NCT04707053
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

The hypothesis is that the structural documentation and analysis of the data of demographics, neuroimaging, IONM and clinical outcomes can help to further standardize the use of such equipment for detecting the integrity of the corticospinal tracts.

We want to confirm that the retrospectively data analysis of neuroimaging, IONM and clinical outcomes does help to understand these methods better in the surgical management of brainstem lesions, and therefore, improve the safety of brainstem surgery.

Detailed Description

This will be a prospective data collection and retrospective data analysis study to investigate the effect of pre- and post-neuroimaging, intraoperative monitoring, and clinical outcome during the surgical management of brainstem lesions in our neurosurgical center. The data of demographics, neuroimaging, IONM and patients' outcomes will be acquired based on the medical records and follow-up visits. All data is stored in the personal file of the clinical information system for each patient. The expected duration of each subject's participation is confined to the surgery itself and the routine visits during the follow-up. The overall study duration is expected to collect all the brainstem surgery in next five years.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients age 18 - 80 years' old
• With lesions in or near the brainstem
• Patients who are suitable for brainstem surgery
• Patients who accept the surgery
• Patients who signed the informed consent

Exclusion Criteria

• Patients age < 18 years
• Patients who are not suitable for brainstem surgery (for example patients in coma, very small lesion, pregnancy)
• Patients unlikely to attend the follow-up 12 months after surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data of direct brainstem stimulation and clinical outcome	09/2020-12/2021	The measurement of stimulation intensity (in mA) and its corresponding neurophysiological outcome (positive or not), as well as the short- and long-term neurological outcome (mRS 0-6) help the standardization of direct brainstem stimulation and clinical outcome prediction

Trial Locations

Locations (1)

Kantonsspital St.Gallen; 🇨🇭 Saint Gallen, Switzerland