Auricular Vagal Nerve Stimulation for Spinal Fusion Surgery
(TAPIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if auricular vagal nerve stimulation, a therapy involving nerve stimulation, can manage pain and inflammation after long-segment spinal fusion surgery. Researchers will compare real stimulation to a sham (fake) version to assess any true benefits. Candidates for this trial include those undergoing extensive spinal fusion surgery, specifically involving spinal segments from L2 to the pelvis or C2 to T2. Participants must be capable of undergoing reliable neurological and pain assessments. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new pain management therapies.
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are undergoing treatment with immunosuppressive drugs.
What prior data suggests that auricular vagal nerve stimulation is safe for spinal fusion surgery?
Research has shown that auricular vagal nerve stimulation (aVNS) is generally safe. A review of several studies found that aVNS can be an effective and safe non-drug treatment for certain long-term health issues, typically without causing serious side effects.
Other studies have used aVNS as a non-opioid method for pain management, indicating its safety for most patients. Some individuals report mild discomfort at the device site, but adjusting the intensity often resolves this issue.
Overall, evidence supports aVNS as a safe option for most people when used under medical supervision.12345Why are researchers excited about this trial?
Researchers are excited about auricular vagal nerve stimulation for spinal fusion surgery because it offers a novel approach to managing pain and recovery. Unlike traditional pain management methods, which often rely on medications like opioids, this technique uses mild electrical impulses to stimulate the vagus nerve through the ear, potentially reducing pain and inflammation without the side effects of drugs. Additionally, the non-invasive delivery method, using adhesive contacts on the ear, provides a simple and patient-friendly alternative. This innovative method could enhance recovery times and improve patient outcomes after surgery.
What evidence suggests that auricular vagal nerve stimulation is effective for spinal fusion surgery?
Research has shown that stimulating the vagus nerve in the ear, known as auricular vagal nerve stimulation (VNS), might help manage pain and swelling after spinal fusion surgery. In this trial, participants will receive either actual VNS or a sham version to compare outcomes. Other studies have found that VNS may also reduce pain and improve outcomes for people with long-term back and stomach pain. By activating the vagus nerve, VNS can help control pain and inflammation in the body. Some patients have reported less swelling, better pain management, and improved blood sugar levels after receiving VNS. Although more research is needed specifically for spinal fusion, these findings suggest that VNS could aid in recovery and comfort after surgery.13678
Are You a Good Fit for This Trial?
This trial is for patients undergoing long-segment spinal fusion surgery who may have conditions like diabetes, pneumonia, or other spinal and neurological disorders. It aims to see if auricular vagal nerve stimulation can help with inflammation and pain after surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive auricular vagal nerve stimulation twice on the day of surgery and twice daily during their postoperative hospital admission
Follow-up
Participants are monitored for safety and effectiveness after treatment, including tracking of post-hospitalization disposition and readmission rates
What Are the Treatments Tested in This Trial?
Interventions
- Auricular Vagal Nerve Stimulation
Trial Overview
The study tests non-invasive ear-based vagus nerve stimulation against a sham (fake) procedure to check its effects on inflammation markers, blood sugar control, post-surgery pain, and recovery outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive vagal nerve stimulation twice on the day of surgery (once preoperatively) and twice daily postoperatively for duration of hospitalization. All patients will be fitted with the device via adhesive contacts to the left ear. Stimulation will occur for 20 minutes per session. The intervention will provide stimulation according to the following parameters: frequency 20 Hz, pulse width 250 µm, and fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation
Participants will have an auricular vagal nerve stimulator device applied in the same manner as the experimental arm, but they will not receive the actual stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexander T. Yahanda
Lead Sponsor
Citations
Auricular Vagal Nerve Stimulation for Spinal Fusion Surgery
This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/83a045e6250fdc06/nct07218133-trans-auricular-stimulation-postoperative-inflammation-spine-surgeryAuricular Vagal Nerve Stimulation for Spinal Fusion Surgery
While these procedures can produce excellent results with regards to postoperative alignment, neural decompression, and functional improvement, ...
Clinical Efficacy of Auricular Vagus Nerve Stimulation in the ...
The use of auricular vagus nerve stimulation can be an effective supplement to multimodal pain management for chronic back pain, abdominal pain ...
4.
app.trialscreen.org
app.trialscreen.org/trials/auricular-vagal-nerve-stimulation-spinal-fusion-surgery-trial-nct07218133Auricular Vagal Nerve Stimulation for Spinal Fusion Surgery
Participants may experience reduced inflammation, better pain control, improved blood sugar levels, fewer complications, and better overall ...
Neurorehabilitation with vagus nerve stimulation
Our review suggests that VNS (non-invasive or invasive) paired with rehabilitation can improve motor outcomes after stroke in humans.
Auricular Vagal Nerve Stimulation for Spinal Fusion Surgery
This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory ...
Transcutaneous Auricular Neurostimulation After Lumbar ...
The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients ...
The Effect of In-Ear and Behind-Ear Transcutaneous ...
In-ear TaVNS appears to be more effective than behind-ear TaVNS in modulating SBP and RMSSD, but this needs to be studied in larger populations.
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