aDBS OUD - Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
Study Basics
Are you over the age of 18 and diagnosed with severe Opioid Use Disorder (OUD) that did not respond to available treatments? If so, you may be eligible to participate in a study that uses deep brain stimulation to treat opioid use disorder.
Study Purpose
The purpose of this study is to determine if personalized Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes like reductions in craving and opioid use. The devices used in this study are investigational for OUD, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD.
Could this study be right for you?
Eligible participants are:
- Between the ages of 22 and 75 years old
- Diagnosed with severe Opioid Use Disorder (OUD)
- Been unable to achieve sustained remission over the past 5 years
- Willing to start outpatient buprenorphine treatment
What participants can expect
Prior to enrollment, study participants will begin outpatient treatment with burprenorphine which will continue throughout the duration of the trial.
During the first brain surgery, temporary electrodes are implanted in multiple brain regions and participants are monitored in the hospital for up to 2 weeks of testing. If brain stimulation significantly improves opioid craving, then participants will transition to the next phase.
In the second phase, a second brain surgery will be done to place a DBS system that can measure brain activity as well as deliver DBS stimulation therapy at home. The study will involve frequent visits over 1.5 to 2 years and we will work with participants to develop a personalized therapy to treat their opioid use disorder.
At the end of the study, participants will have the opportunity for the DBS system to be removed or keep it. They will also have the opportunity to continue care with a UCSF clinician.
Study participants will be compensated for their time and effort.
IRB: 25-43357 - Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder
Learn More about Medtronic's Percept DBS System
Contact the Research Team if you are interested in participating
Study Personnel
Khaled Moussawi, MD, PhD
Principal Investigator
Associate Professor in Residence in the departments of Neurology and Psychiatry at UCSF with extensive experience in substance use disorders and neuromodulation. Dr. Moussawi is board-certified by the American Board of Psychiatry and Neurology.
Kristin Sellers, PhD
Co-Principal Investigator
Dr. Sellers is an Assistant Adjunct Professor in the Department of Neurological Surgery. She studies intracranial electrical stimulation for the treatment of neuropsychiatric disorders including major depressive disorder and chronic pain. She works to translate learnings from early stage clinical trials of closed-loop neuromodulation for the development of neurotechnologies and supporting infrastructure.
Edward Chang, MD
Investigator
Dr. Chang specializes in advanced brain mapping methods to preserve crucial areas for speech and motor functions in the brain. He also has extensive experience with implantable devices that stimulate specific nerves to relieve seizure, movement, pain and other disorders.
Philip Starr, MD, PhD
Investigator
Dr. Starr is Professor of Neurological Surgery and holds the Dolores Cakebread Endowed Chair in Neurological Surgery. His clinical interests are in functional neurosurgery, especially in the use of implanted devices to improve brain function.
Ru Zhang, PhD
Assistant Researcher
Ru Zhang is an assistant professional researcher with a background in cognitive psychology and neuroscience. She received her PhD in mathematical and computational cognitive science from Purdue University
Kelly Kadlec, PhD
Postdoctoral Scholar
Kelly Kadlec is a postdoctoral researcher with a background in electrical engineering and neuroscience. She received her PhD in Neurobiology from Caltech.
Brooke Staveland, PhD
Postdoctoral Scholar
Brooke Staveland is a postdoctoral researcher with a background in clinical psychology and neuroscience. She received her PhD in Neuroscience from UC Berkeley
Catherine Borror, BS, CCRP
Senior Clinical Research Coordinator
Catherine Borror is a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA) with experience in study design and coordination at UCSF working in the Neurology Department.
Sierra Brandts, BS
Clinical Research Coordinator
Sierra Brandts is a Clinical Research Coordinator with experience in neurophysiology from the University of the South.
Ananya Madhusudhan, MS
Clinical Research Coordinator
Ananya Madhusudhan is a Clinical Research Coordinator with experience in Biomedical Engineering from Northeastern University.