Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06495580
Status
Not Yet Recruiting

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Conditions

  • Optic Nerve Injuries
  • Sellar Tumor
  • Skull Base Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Optic Nerve Stimulation — PROCEDURE
    Anterograde Stimulation of the Optic Neve.

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Jul 2024
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Optic Nerve Stimulation
    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.
  • No Intervention: No Intervention
    Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series.

Primary Outcome Measure

Visual Deficits [ Time Frame: 6 weeks after surgery date. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Daniel Quintana
[email protected]
909-441-8999

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By research site
University of California, San Francisco· San Francisco, CA

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