Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches

NCT06495580 | Not Yet Recruiting

• 1 other identifier: 24-41739
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Nerve Injuries; Sellar Tumor; Skull Base Neoplasms

Outcome Measures

Primary Outcomes (1)

• Visual Deficits

  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.

  6 weeks after surgery date.

Study Arms (2)

Optic Nerve Stimulation

EXPERIMENTAL

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.

Procedure: Optic Nerve Stimulation

No Intervention

NO INTERVENTION

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

Interventions

Optic Nerve Stimulation PROCEDURE

Anterograde Stimulation of the Optic Neve.

Optic Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (11)

• Margalit NS, Lesser JB, Moche J, Sen C. Meningiomas involving the optic nerve: technical aspects and outcomes for a series of 50 patients. Neurosurgery. 2003 Sep;53(3):523-32; discussion 532-3. doi: 10.1227/01.neu.0000079506.75164.f4.

  PMID: 12943569 BACKGROUND

• Cohen AR, Cooper PR, Kupersmith MJ, Flamm ES, Ransohoff J. Visual recovery after transsphenoidal removal of pituitary adenomas. Neurosurgery. 1985 Sep;17(3):446-52. doi: 10.1227/00006123-198509000-00008.

  PMID: 4047355 BACKGROUND

• Jashek-Ahmed F, Cabrilo I, Bal J, Sanders B, Grieve J, Dorward NL, Marcus HJ. Intraoperative monitoring of visual evoked potentials in patients undergoing transsphenoidal surgery for pituitary adenoma: a systematic review. BMC Neurol. 2021 Jul 23;21(1):287. doi: 10.1186/s12883-021-02315-4.

  PMID: 34301198 BACKGROUND

• Newman S. A prospective study of cavernous sinus surgery for meningiomas and resultant common ophthalmic complications (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2007;105:392-447.

  PMID: 18427624 BACKGROUND

• Carnevale JA, Babu CS, Goldberg JL, Fong R, Schwartz TH. Visual deterioration after endonasal endoscopic skull base surgery: causes, treatments, and outcomes. J Neurosurg. 2021 Oct 1;136(4):1103-1113. doi: 10.3171/2021.3.JNS204378. Print 2022 Apr 1.

  PMID: 34598134 BACKGROUND

• Sakata K, Komaki S, Takeshige N, Negoto T, Kikuchi J, Kajiwara S, Orito K, Nakamura H, Hirohata M, Morioka M. Visual Outcomes and Surgical Approach Selection Focusing on Active Optic Canal Decompression and Maximum Safe Resection for Suprasellar Meningiomas. Neurol Med Chir (Tokyo). 2023 Sep 15;63(9):381-392. doi: 10.2176/jns-nmc.2021-0142. Epub 2023 Jul 10.

  PMID: 37423756 BACKGROUND

• Chung SB, Park CW, Seo DW, Kong DS, Park SK. Intraoperative visual evoked potential has no association with postoperative visual outcomes in transsphenoidal surgery. Acta Neurochir (Wien). 2012 Aug;154(8):1505-10. doi: 10.1007/s00701-012-1426-x. Epub 2012 Jun 29.

  PMID: 22739773 BACKGROUND

• Qiao N, Yang X, Li C, Ma G, Kang J, Liu C, Cao L, Zhang Y, Gui S. The predictive value of intraoperative visual evoked potential for visual outcome after extended endoscopic endonasal surgery for adult craniopharyngioma. J Neurosurg. 2021 May 7;135(6):1714-1724. doi: 10.3171/2020.10.JNS202779. Print 2021 Dec 1.

  PMID: 33962373 BACKGROUND

• Benedicic M, Bosnjak R. Intraoperative monitoring of the visual function using cortical potentials after electrical epidural stimulation of the optic nerve. Acta Neurochir (Wien). 2011 Oct;153(10):1919-27. doi: 10.1007/s00701-011-1098-y. Epub 2011 Aug 5.

  PMID: 21818643 BACKGROUND

• Sasaki T, Itakura T, Suzuki K, Kasuya H, Munakata R, Muramatsu H, Ichikawa T, Sato T, Endo Y, Sakuma J, Matsumoto M. Intraoperative monitoring of visual evoked potential: introduction of a clinically useful method. J Neurosurg. 2010 Feb;112(2):273-84. doi: 10.3171/2008.9.JNS08451.

  PMID: 19199497 BACKGROUND

• Benedicic M, Bosnjak R. Optic nerve potentials and cortical potentials after stimulation of the anterior visual pathway during neurosurgery. Doc Ophthalmol. 2011 Apr;122(2):115-25. doi: 10.1007/s10633-011-9265-2. Epub 2011 Mar 16.

  PMID: 21409432 BACKGROUND

MeSH Terms

Conditions

Optic Nerve Injuries; Skull Base Neoplasms

Condition Hierarchy (Ancestors)

Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases; Wounds and Injuries; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ezequiel Goldschmidt, MD, PhD

  UCSF Department of Neurological Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezequiel Goldschmidt, MD, PhD

CONTACT

415.514.6482; eze.goldschmidt@ucsf.edu

Daniel Quintana, BA

CONTACT

9094418999; Daniel.Quintana@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will enroll adult (18 y.o. and older) patients undergoing open or endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)