60 Participants Needed

Auricular Neurostimulation for Chronic Pain

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Medical Branch, Galveston
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a device worn on the ear might help people with chronic pain. It uses gentle electrical stimulation, known as Transcutaneous Auricular Neurostimulation, to potentially alter how the brain perceives pain and manage withdrawal symptoms. Participants will receive either real or sham stimulation to compare effects. This trial suits those who have experienced pain for more than half the days in the last six months and are willing to reduce their opioid use by at least 10%. Participants will stay in a research center for a few days for close monitoring. As an unphased trial, this study offers a unique opportunity to explore innovative pain management solutions.

Will I have to stop taking my current medications?

You will need to reduce your pain medication by at least 10% as part of the study. The protocol does not specify stopping other medications, but you must not be taking benzodiazepines or have a high opioid dose.

What prior data suggests that this auricular neurostimulation device is safe for reducing chronic pain?

Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe. Studies have found that this technique usually causes only mild and short-lasting side effects. In trials involving individuals with knee osteoarthritis, tAN was considered a safe treatment option, potentially serving as a good alternative to more invasive procedures.

The FDA has already approved the device used for this treatment, further supporting its safety. Any side effects are typically temporary and not serious. Participants can adjust the stimulation level to maintain comfort during the procedure.

Overall, evidence suggests that tAN is a well-tolerated option for managing pain, with minimal risk to participants.12345

Why are researchers excited about this trial?

Researchers are excited about transcutaneous auricular neurostimulation (tAN) for chronic pain because it offers a novel, non-invasive approach that differs from traditional pain management methods like medications or invasive procedures. Unlike typical treatments that often come in the form of pills or injections, tAN uses a wearable device to deliver electrical stimulation to the ear, targeting specific nerves associated with pain relief. This innovative delivery method could potentially reduce side effects associated with conventional pain medications, providing a safer and more comfortable option for those suffering from chronic pain.

What evidence suggests that this device is effective for chronic pain?

Research has shown that transcutaneous auricular neurostimulation (tAN) can help reduce chronic pain. This trial will compare active tAN stimulation with a sham version to evaluate its effectiveness. The method stimulates nerves in the ear and has made a noticeable difference in managing pain. It targets the vagus and trigeminal nerves, which play important roles in processing pain signals in the brain. For individuals with long-term pain conditions, tAN has effectively reduced pain symptoms. This non-invasive treatment does not involve surgery or needles, making it more appealing. Overall, previous patients reported improvements in their pain levels with tAN therapy.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with chronic pain, who are on opioid medication and willing to reduce their dose by at least 10%. They must not have a history of seizures, neurological diseases, or ear problems. Participants should test negative for illicit drugs and nonprescribed opioids but positive for prescribed ones. Pregnant women or those at risk of pregnancy without proper contraception are excluded.

Inclusion Criteria

I understand the study and can make decisions about my participation.
I want to lower or stop my opioid medication.
I am willing to reduce my opioid dose by at least 10%.
See 6 more

Exclusion Criteria

I have had a neurological disease or a traumatic brain injury.
I am currently taking prescribed benzodiazepine medication.
I take more than 50 MME of opioid pain medication daily.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive either active or sham transcutaneous auricular neurostimulation for two days, with four hours of stimulation each day.

2 days
Continuous stay at Clinical Research Center

Monitoring

Participants are monitored for withdrawal symptoms and complete questionnaires, sensory testing, and MRI scans.

4 days
Continuous stay at Clinical Research Center

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of questionnaires and MRI.

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Neurostimulation
Trial Overview The study tests transcutaneous auricular neurostimulation (TAN), a device worn on the ear believed to alleviate pain and opioid withdrawal symptoms by stimulating nerves. Participants will receive either real TAN or sham (fake) treatment while reducing opioid use over four days in a clinical setting.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: tAN stimulation - activeActive Control1 Intervention
Group II: tAN stimulation - shamPlacebo Group1 Intervention

Transcutaneous Auricular Neurostimulation is already approved in United States, European Union for the following indications:

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Approved in United States as Transcutaneous Auricular Neurostimulation for:
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Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials
263
Recruited
55,400+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Published Research Related to This Trial

Vagus nerve stimulation (VNS), particularly through non-invasive methods like transcutaneous VNS (tVNS), shows promise for treating various clinical disorders, including heart failure and migraines, by stimulating the auricular branch of the vagus nerve without the need for surgical implantation.
Current research highlights the need for more detailed studies on the neuroanatomy of the auricular branch of the vagus nerve (ABVN) to better understand its therapeutic effects and optimize stimulation parameters, as existing literature lacks consensus on the most effective stimulation sites.
The anatomical basis for transcutaneous auricular vagus nerve stimulation.Butt, MF., Albusoda, A., Farmer, AD., et al.[2022]
In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.
Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.
Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review.Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]
Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and well-tolerated method for treating conditions like drug-resistant epilepsy, but a recent randomized double-blind trial found no significant difference in outcomes between high- and low-stimulation groups.
The most common side effect of taVNS is a tingling sensation or pain at the stimulation site, and while it shows promise, further research is needed to fully understand its efficacy and to potentially gain approval for insurance coverage in Japan.
[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation].Yamamoto, T.[2022]

Citations

Clinical Efficacy of Auricular Vagus Nerve Stimulation in the ...The aim of this systematic review and meta-analysis is to evaluate the clinical efficacy and safety of aVNS in treating chronic and acute pain conditions.
Transcutaneous vagus nerve stimulation effects on chronic paintVNS reduces pain in chronic pain conditions, making a measurable clinical impact. Future research should aim to understand the bottom-up (or top-down) effects ...
O116 TRANSCUTANEOUS AURICULAR VAGUS NERVE ...The purpose of this study is to investigate the modulation effects of transcutaneous auricular vagus nerve stimulation (taVNS) on cLBP as well as its potential ...
Understanding the Effects of Transcutaneous Auricular ...The purpose of the study is to find out how a stimulation device worn on the ear works. This device is thought to stimulate nerves in the area around the ...
Efficacy and Safety of Transcutaneous Auricular Vagus ...The study manifested that noninvasive taVNS effectively improved constipation and abdominal pain symptoms in patients with IBS-C. The alleviation of IBS-C ...
Safety of transcutaneous auricular vagus nerve stimulation ...Although the general impression is that taVNS is a safe technique with only mild and transient adverse effects (AEs), human data on safety and ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39687279/
Safety and preliminary efficacy of transcutaneous auricular ...Our preliminary data demonstrated that tVNS may be a safe pain-relieving treatment for people with knee OA.
Transcutaneous Auricular Vagus Nerve StimulationtaVNS may be a safer alternative to invasive vagal nerve stimulation for treating treatment-resistant mood disorders, chronic pain, inflammation, cardiovascular ...
Effects of Transcutaneous Auricular Vagus Nerve ...The investigators will assess outcomes including pain intensity, sleep quality, central sensitization, and fear of movement (kinesiophobia). Detailed ...
Safety and preliminary efficacy of transcutaneous auricular ...Our preliminary data demonstrated that tVNS may be a safe pain-relieving treatment for people with knee OA. Our findings suggest that improvement of knee pain ...
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