Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

NCT ID: NCT06495580

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

Our hypothesis is that utilizing anterograde optic nerve microstimulation during open and endoscopic cranial approaches will allow for more accurate and real-time assessment of optic nerve function compared to the current standard of Visual Evoked Potentials. The investigators predict that this novel approach will lead to improved intraoperative monitoring and better correlation with post- surgical clinical outcomes.

The study design proposed is interventional and prospective. It involves implementing a novel approach, anterograde optic nerve microstimulation, during surgical procedures to assess optic nerve integrity. This design entails actively intervening during the surgical process to stimulate the optic nerve and record responses, indicating an interventional approach.

Conditions

Optic Nerve Injuries; Sellar Tumor; Skull Base Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Optic Nerve Stimulation

Intervention Type: PROCEDURE

Anterograde Stimulation of the Optic Neve.

No Intervention

Patients receiving regular standard of care in endoscopic endonasal approaches within the same case series.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Optic Nerve Stimulation

Anterograde Stimulation of the Optic Neve.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.
• Must not present with any permanent or temporal visual deficit.
• Must receive an open or endoscopic endonasal procedure as part of their care.

Exclusion Criteria

• Preexisting visual impairments unrelated to the tumor.
• History of prior cranial surgeries or radiation therapy.
• Significant cognitive impairment or inability to provide informed consent
• Contraindications to microstimulation procedures such as uncontrolled coagulopathy or active infection.
• Patients with tumors located outside the sellar region or those requiring emergent or urgent surgery due to life-threatening complications.
• Additionally, individuals with systemic conditions or comorbidities that may significantly impact visual function or surgical outcomes, such as uncontrolled diabetes mellitus or severe cardiovascular disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ezequiel Goldschmidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Department of Neurological Surgery

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Central Contacts

Ezequiel Goldschmidt, MD, PhD

Role: CONTACT

eze.goldschmidt@ucsf.edu

415.514.6482

Daniel Quintana, BA

Role: CONTACT

Daniel.Quintana@ucsf.edu

9094418999

Facility Contacts

Daniel Quintana

Role: primary

Daniel.Quintana@ucsf.edu

909-441-8999

References

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Other Identifiers

24-41739

Identifier Type: -

Identifier Source: org_study_id