Recording of Intraoperative Spinal Cord Stimulation and Monitoring

NCT ID: NCT05356286

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-21

Study Completion Date

2027-01-22

Brief Summary

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Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.

Detailed Description

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Conditions

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Cervical Stenosis Disk, Herniated Spondylosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrical Stimulation group

Epidural Electrical Stimulation of the Cervical Spinal Cord

Group Type EXPERIMENTAL

epidural electrical stimulation

Intervention Type DEVICE

Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.

Interventions

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epidural electrical stimulation

Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lu, MD, PhD

Professor, Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Lu, MD

Role: CONTACT

310/825/4321

Facility Contacts

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Daniel Lu, MD

Role: primary

310-825-4321

Other Identifiers

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11-000043

Identifier Type: -

Identifier Source: org_study_id

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