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NCT Number: NCT06495580

Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location contact

Daniel Quintana

CONTACT

[email protected]

909-441-8999

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optic Nerve Stimulation

Procedure

Anterograde Stimulation of the Optic Neve.

Primary outcomes

  1. Visual Deficits

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Quintana, BA

CONTACT

[email protected]

9094418999

Ezequiel Goldschmidt, MD, PhD

CONTACT

[email protected]

415.514.6482

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Optimizing Visual Outcomes: Use of Optic Nerve Stimulation in Endoscopic Cranial Approaches

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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