Data Collection and Analysis in Brainstem Surgeries

Surgery Clinical Trial

Official title:

Data Collection and Analysis of Neuroimaging and Intraoperative Neurophysiological Monitoring (IONM) in Brainstem Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707053
• Other study ID #: 2020-02088
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: Yang Yang
• Phone: +41779861318
• Email: yang.cne.yang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brainstem Lesion
• Intraoperative Neurophysiologic Monitoring
• Surgery

Locations

Country	Name	City	State
Switzerland	Kantonsspital St.Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data of direct brainstem stimulation and clinical outcome	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	09/2020-12/2021