Cervical StenosisNCT05356286
Recording of Intraoperative Spinal Cord Stimulation and Monitoring
A study testing epidural electrical stimulation in people with Cervical Stenosis and Disk, Herniated, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Stenosis, Disk, Herniated, Spondylosis
- What is being tested?
- epidural electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2011to 22 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Daniel Lu, MD, 310-825-4321, dclu@mednet.ucla.edu
About this study
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.
- Conditions
- Cervical Stenosis, Disk, Herniated, Spondylosis
- Being tested
- epidural electrical stimulation
- Medical subject headings
- Intervertebral Disc Displacement, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural electrical stimulationDevice
Electrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation group | Experimental | Epidural Electrical Stimulation of the Cervical Spinal Cord Receives: Device: epidural electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory frequency
Increase or decrease in respiratory frequency of 20% during or after stimulation
Measured: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Change in respiratory tidal volume
Increase or decrease in respiratory tidal volume of 20% during or after stimulation
Measured: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Secondary outcomes (2)
Change in heart rate
Increase or decrease in heart rate of 20% during or after stimulation
Measured: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Change in blood pressure
Increase or decrease in blood pressure of 20% during or after stimulation
Measured: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start21 Jan 2011
- Primary completion22 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical StenosisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lu, MD, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356286
- Sponsor's protocol ID
- 11-000043
- Status last verified
- Mar 2025
- First submitted
- 22 Apr 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording of Intraoperative Spinal Cord Stimulation and Monitoring
- ClinicalTrials.gov ID
- NCT05356286
- Acronym / sponsor ID
- 11-000043
- Conditions
- Cervical Stenosis, Disk, Herniated, Spondylosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 21 Jan 2011 (actual)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation group | Experimental | Device: epidural electrical stimulationEpidural Electrical Stimulation of the Cervical Spinal Cord |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural electrical stimulationElectrical spinal cord stimulation will be used to modulate respiratory function during general anesthesia. | Device | Electrical Stimulation group |
Primary outcome
Change in respiratory frequency
Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Increase or decrease in respiratory frequency of 20% during or after stimulation
Change in respiratory tidal volume
Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Increase or decrease in respiratory tidal volume of 20% during or after stimulation
2 secondary outcomes
Change in heart rate
Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Change in blood pressure
Time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Cervical Stenosis
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Recruiting
Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation.
Cervical Stenosis, Cervical Spine
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruitingPhase 2
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural electrical stimulation in people with Cervical Stenosis and Disk, Herniated, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lu, MD (310/825/4321, dclu@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in respiratory frequency (time frame: During intraoperative surgery during stimulation and within 2 minutes after stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.