Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

Not Applicable

Not yet recruiting

• Conditions: Skull Base Neoplasms; Optic Nerve Injuries; Sellar Tumor
• Interventions: Procedure: Optic Nerve Stimulation

• Registration Number: NCT06495580
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-10
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Study Start: 2024-08
• Primary Completion: 2026-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optic Nerve Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Visual Deficits	6 weeks after surgery date.	Patients that received our intervention will be evaluated post operatively for regular standard of care six weeks post-operatively. During visual evaluation, the PI of this study will determine post-operative visual field and visual acuity. These parameters will be compared to pre-operative visual acuity and visual field status.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States