Brainstem LesionNCT04707053
Data Collection and Analysis in Brainstem Surgeries
An observational study of Brainstem Lesion and Surgery, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brainstem Lesion, Surgery, Intraoperative Neurophysiologic Monitoring
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2020to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients with lesions in or near brainstem who accept surgical resection as the optimal treatment. Estimation of 50 participants in the intra-axial brainstem surgical group, and 150 in the extra-axial brainstem surgical group. There is no other patient collective that could be used as substitute for the study population.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital St.Gallen
Sankt Gallen, 9000
Yang Yang, 0779861318, yang.cne.yang@gmail.com
About this study
Official title: Data Collection and Analysis of Neuroimaging and Intraoperative Neurophysiological Monitoring (IONM) in Brainstem Surgeries
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraaxial lesion group | Patients with intraaxial brainstem lesions (lesions located in the brainstem) + experienced brainstem surgery in our department during the study period | |
| Extraaxial lesion group | Patients with extraaxial brainstem lesions (lesions close to the brainstem) + experienced brainstem surgery in our department during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 09/2020-12/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Sep 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brainstem LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Yang, MD, Cantonal Hospital of St. Gallen
- Investigators
- Oliver Bozinov, Prof, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707053
- Sponsor's protocol ID
- 2020-02088
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection and Analysis of Neuroimaging and Intraoperative Neurophysiological Monitoring (IONM) in Brainstem Surgeries
- ClinicalTrials.gov ID
- NCT04707053
- Acronym / sponsor ID
- 2020-02088
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraaxial lesion group | – | –Patients with intraaxial brainstem lesions (lesions located in the brainstem) + experienced brainstem surgery in our department during the study period |
| Extraaxial lesion group | – | –Patients with extraaxial brainstem lesions (lesions close to the brainstem) + experienced brainstem surgery in our department during the study period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with lesions in or near brainstem who accept surgical resection as the optimal treatment. Estimation of 50 participants in the intra-axial brainstem surgical group, and 150 in the extra-axial brainstem surgical group. There is no other patient collective that could be used as substitute for the study population.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data of direct brainstem stimulation and clinical outcome
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Bozinov, Prof study chair
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brainstem Lesion and Surgery, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yang (+41779861318, yang.cne.yang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data of direct brainstem stimulation and clinical outcome (time frame: 09/2020-12/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.