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Optic Nerve Stimulation for Skull Base Tumors

N/A
Waitlist Available
Led By Ezequiel Goldschmidt, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients diagnosed with suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.
* Must not present with any permanent or temporal visual deficit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after surgery date.
Awards & highlights

Summary

Assessing the function of the optic nerve is paramount during various neurosurgical procedures. Effective optic nerve monitoring has remained elusive as Visual Evoked Potentials (the current existing tool) provides only diffuse and delayed assessment of nerve function. Here, the investigators propose a prospective study involving adult patients (aged 18 years and older) undergoing endonasal or open cranial approaches around the optic nerves, who will receive pre- and post-operative visual evaluations. During surgery, the optic nerve and chiasm will be stimulated, and the response will be recorded in both eyes and the occipital cortex via skin electrodes. The investigators aim to utilize anterograde optic nerve microstimulation to assess the nerve's integrity during open and endoscopic cranial approaches. Electrophysiological readings will be acquired, as is routine in the operating room, by our team of experts, and intraoperative findings will be correlated with post- surgical clinical outcomes. Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.

Who is the study for?
This trial is for adults over 18 who are undergoing surgery for skull base or pituitary tumors that may affect the optic nerve. Participants must be able to undergo pre- and post-operative visual evaluations.
What is being tested?
The study tests a new way to monitor the optic nerve during surgery by stimulating it and recording responses. This could provide real-time, accurate assessments of nerve function to prevent damage.
What are the potential side effects?
Since this intervention involves monitoring during surgery rather than a drug or device implantation, side effects are likely minimal but may include discomfort from skin electrodes used for recording responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after surgery date.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after surgery date. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual Deficits

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Optic Nerve StimulationExperimental Treatment1 Intervention
The most significant procedure will be using an anterograde microstimulator and provoke stimulations to the optic nerve as the surgery proceeds. During surgery, the optic nerve and chiasm will be stimulated and the response recorded in both eyes and occipital cortex via skin electrodes. These responses will be monitored at all times by the neuromonitorig team who will inform if changes in neural responses change. The use of microstimulator has been proven safe in other surgical approaches.
Group II: No InterventionActive Control1 Intervention
Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,548 Previous Clinical Trials
15,264,431 Total Patients Enrolled
Ezequiel Goldschmidt, MD, PhDPrincipal InvestigatorUCSF Department of Neurological Surgery
1 Previous Clinical Trials
40 Total Patients Enrolled
~13 spots leftby Aug 2026