A clinical trial testing the wearable device as a treatment for chronic pain and opioid withdrawal

Collaborative research awarded to the College of Texas Medical Department, the Medical College of South Carolina, and Spark Biomedical

Sparrow Rise

Wearable neurostimulation to relieve opioid withdrawal

Wearable neurostimulation to alleviate opioid withdrawal

GALVESTON, TX, Jan. 17, 2023 (GLOBE NEWSWIRE) — A multi-year medical trial on the College of Texas Medical Department (UTMB) and Medical College of South Carolina (MUSC) will study using a wearable system believed to stimulate nerves close to the ear to change indicators within the mind as a remedy for ache. Power and diminished opioid use.

The trial, generally known as tANdem, is funded by an $8.8 million grant from the Nationwide Institute of Neurological Issues and Stroke and the Nationwide Institutes of Well being and is designed to offer an understanding of the mechanistic, neurophysiological and antinociceptive results of transcutaneous auricular nerve stimulation (tAN), which has been proven to alleviate ache and withdrawal signs.

“The opioid disaster has generated untold deaths and persistent disabilities which have had a major influence on international healthcare,” stated Dr. “Our collaborative challenge will decide the efficacy of TAN for relieving real-world affected person tapers from opioid administration for persistent ache with diminished withdrawal signs. Importantly, neurostimulation remedy will present an progressive and much-needed remedy choice over present opioid analgesics with excessive dangers of abuse, opioid use dysfunction, and opioid overdose.” extra.”

Amid the opioid epidemic, a remedy hole has emerged. Numerous sufferers are inspired to keep away from or cease utilizing opioids to alleviate acute ache and persistent ache circumstances for which opioids are a day by day necessity. Suppliers should stability the necessity to cut back the hurt of opioids whereas concurrently managing the affected person’s ache. Inside this hole, non-opioid and non-drug options may present the a lot wanted reply.

Neurostimulation gadgets that concentrate on the cranial nerves have lengthy been used to manage ache. Particularly, stimulation of the vagus nerve (VNS) and trigeminal nerve (TNS) has confirmed profitable as an analgesic for acute ache, postoperative ache, and persistent ache problems.

Wearable tanning remedy, which mixes VNS and TNS, has the potential to considerably enhance ache administration by offering a protected, efficient, and handy technique of facilitating acute and long-term ache aid with out the dangers related to opioids or different ache medicines or the necessity for disposable gadgets. For implants utilized in lots of the present neuromodulation therapies.

Spark Biomedical has developed the Sparrow Remedy System – the primary FDA-cleared, non-invasive wearable system for the remedy of opioid withdrawal. The usage of the Sparrow system for ache administration will probably be investigated on this trial, which will probably be a pioneering multi-site collaborative effort bringing collectively consultants in ache, dependancy, neurostimulation, and neuroimaging.

The trial is led by principal investigator Denise Wilkes, MD, PhD, UTMB Professor, Division of Anesthesiology and Ache Drugs. David Hutton, Ph.D., UTMB Assistant Professor, Division of Psychiatry and Behavioral Sciences; Bashar Badran, Ph.D., Assistant Professor, School of Drugs, Moscow College, Division of Psychiatry and Behavioral Sciences; and Naveed Khodapharast, Ph.D., co-founder of Spark Biomedical and Chief Science Officer. Co-investigators embody Katherine Cunningham, PhD, UTMB Professor, Division of Pharmacology. Jeffrey Burkhardt, MUSC Professor, Division of Psychiatry and Behavioral Sciences; and Melanie McQuaid, PhD, Spark’s director of medical operations.

“Over the previous 15 years of learning the evolution of tolerance to opioid analgesics, I’ve discovered larger tolerance to larger doses of opioids in animal fashions and have seen comparable opioid tolerance and dissatisfaction with remedy with excessive doses of opioids in my sufferers,” stated Wilkes, MD. Ache and researcher on the College of UTMB. “My group and I’ve developed and deployed methods to assist wean sufferers off excessive doses of opioids and we’re discovering dramatic modifications in sufferers’ lives with dose reductions. We have an interest within the administration and remedy of trigeminal neuralgia and trigeminal neuralgia and the way this impacts emotional stability and persistent ache.

“I’m excited to see how this know-how to stimulate the trigeminal nerve and the vagus nerve might help sufferers with persistent ache management their use of opioids and assist them get by means of these occasions of opioid disaster,” stated Wilkes.

Houghton, a medical psychologist at UTMB, stated the varied group of researchers is vital to this effort.

“An enormous variety of ache sufferers are being prescribed opioids and require simpler methods of coming off these medicines whereas not experiencing excessive ache and withdrawal,” Hutton stated. Vagus and trigeminal auditory stimulation could be a wonderful remedy for this medical drawback; Nevertheless, we have to higher perceive the mechanisms by which the sort of neurostimulation relieves ache and withdrawal. To handle this query, we assembled a various group of scientists and clinicians from academia and trade to conduct a collection of translational research that can advance our understanding of the underlying neurobiological results of Tan. These tasks will type a robust basis of significant science supporting using Tan as a ache intervention, utilizing Tan to assist persistent ache sufferers cut back their use of opioids in addition to maximize affected person responses to tanning.”

Badran, a neuroscientist and director of the MUSC Neuro-X Laboratory, has excessive hopes for the research.

“Accrued knowledge from our lab and others point out that otovagal and trigeminal stimulation strategies activate the central and peripheral nervous techniques,” Badran stated. “We live at a second in historical past the place wearable applied sciences have the potential to dramatically affect how we take care of psychiatric and neurological problems. Sufferers with opiate withdrawal and ache want higher remedy choices. In the end, wearable non-invasive mind stimulation could emerge as a promising non-pharmacological remedy, If we perceive and enhance the way it works.

“We’re excited to make use of the superior neurostimulation and neuroimaging methods developed in our lab to start to know the mechanism behind tan extra realistically.”

Kodaparast of Spark famous, “We imagine that our FDA-approved tan remedy produces analgesic and opioid withdrawal mitigating results. This research will use fMRI mind imaging in contributors with each wholesome and persistent ache to additional elucidate the mechanism of tan. Understanding the mechanism is vital. It’s going to allow future work to enhance dosing parameters, set up safer tapering protocols, and finally enhance ache administration.”

The trial started in late 2022 and can proceed by means of the autumn of 2027.

In regards to the College of Texas Medical Department: The primary tutorial well being heart in Texas opened its doorways in 1891 and right now contains 4 campuses, 5 colleges of well being sciences, 5 institutes for superior research, a analysis establishment that’s house to one in every of solely two nationwide laboratories devoted to the protected research of infectious threats to human well being, a trauma heart from Degree 1 well being system providing a full vary of major and specialty medical providers all through the Texas Gulf Coast area. UTMB is an affiliated establishment of the College of Texas System and a member establishment of the Texas Medical Heart. UTMB is a serious campus of the biomedical sciences with over 1.1 million sq. ft of analysis area and $236 million in presently sponsored analysis funding. Quite a few interdisciplinary facilities of excellence deal with getting old, most cancers, environmental toxicology, structural biology, and tropical ailments. For extra info, go to utmb.edu.

The UTMB Heart for Dependancy Analysis (CAR), an institutional heart of excellence, gives the infrastructure for analysis and training in substance use problems. Directed by Katherine Cunningham, Ph.D., CAR’s mission is to enhance the course of persistent well being problems by understanding organic mechanisms and translating these discoveries into new therapies to extend the standard of life for individuals inside our neighborhood, state, and world. Go to utmb.edu/automobile to study extra.

In regards to the Medical College of South Carolina: Based in 1824 in Charleston, MUSC is the state’s solely complete tutorial well being system, with a singular mission to protect and enhance human life in South Carolina by means of training, analysis, and affected person care. Every year, MUSC educates greater than 3,000 college students in six faculties – dental, graduate, well being professions, medical, nursing and pharmacy – and trains greater than 850 residents and fellows in its well being system. MUSC introduced in additional than $297.8 million in analysis cash in fiscal 12 months 2022, main the state total in analysis funding. For details about tutorial packages, go to caught.

Because the well being care system of the Medical College of South Carolina, MUSC Well being is devoted to offering the very best high quality, most secure care to sufferers whereas educating and coaching generations of excellent well being care suppliers and leaders to serve the individuals of South Carolina and past. Affected person care is supplied at 14 hospitals with almost 2,500 beds and 5 further hospital websites beneath growth; greater than 350 telehealth websites, related to sufferers’ houses; and almost 750 care websites situated all through South Carolina. In 2022, for the eighth consecutive 12 months, US Information & World Report named MUSC Well being the No. 1 hospital in South Carolina. To study extra about our medical affected person providers, go to musclehealth.org.

MUSC and its associates have collective annual budgets totaling $5.1 billion. MUSC’s 25,000 group members embody world-class school, physicians, skilled suppliers, scientists, college students, affiliate companions, and care group members who present and assist groundbreaking training, analysis, and affected person care.

MUSC Neuro-X is a multidisciplinary neuromodulation, engineering, and innovation laboratory situated throughout the Division of Psychiatry and Behavioral Sciences on the Medical College of South Carolina. Based and directed by Bashar Badran, Ph.D., Neuro-X leverages the atmosphere for neurotechnology and innovation to start addressing advanced neuropsychological and medical problems. Study extra by means of NeuroXLab.com.

About Spark Biomedical: Spark Biomedical, Inc. is a number one US-based developer of wearable neurostimulation options devoted to the lifesaving work of serving to 36.3 million individuals worldwide overcome withdrawal, recuperate from dependancy, and obtain the higher high quality of life they deserve. With growing incidences of opioid-related misuse and overdose deaths, the Firm’s mission is to get rid of opioid dependancy by working to handle the total opioid dependancy life cycle, together with managing withdrawal, avoiding opioids, stopping relapse, and assuaging dysfunction Submit-traumatic stress dysfunction.

Spark Biomedical helps sufferers take step one to overcoming acute opioid withdrawal with its FDA-cleared wearable know-how, the Sparrow Remedy System – Transcutaneous Aural Nerve Stimulation (tAN®) for opioid withdrawal aid. Sparrow™ Remedy gives a straightforward, protected and efficient drug-free remedy choice backed by medical proof. Subsequent steps are underway with the launch of two NIDA-funded medical trials to enhance relapse charges in adults and assist infants with neonatal opioid withdrawal syndrome (NOWS). Study extra by means of sparkbiomedical.com.

In regards to the grant: The analysis is supported by the Nationwide Institute of Neurological Issues and Stroke of the Nationwide Institutes of Well being beneath award quantity RM1NS128787. The content material is solely the accountability of the authors and doesn’t essentially signify the official views of the Nationwide Institutes of Well being.


CONTACT: Jackie Powell Spark Biomedical 832-792-0666 jackie.powell@sparkbiomedical.com

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