Key Points
- The research studies are testing low-intensity focused ultrasound neuromodulation for treating tobacco use disorder, opiate use disorder, and chronic pain.
- Because they are taking place at the Washington DC VA Medical Center, enrollment is only open to veterans.
Mary Lee, MD, director of the Psychiatric Neuromodulation Service at the US Department of Veterans Affairs (VA) Washington DC VA Medical Center is leading three clinical trials exploring the use of low-intensity focused ultrasound (LIFU) neuromodulation for treating a variety of neuropsychiatric conditions such as tobacco use disorder, opiate use disorder (OUD), and chronic pain.
Dr. Lee’s team is using the noninvasive Brainbox NeuroFUS device for all three studies, which are currently only open to veterans.
“The field of focused ultrasound neuromodulation is relatively new, but it may have therapeutic potential for individuals with these types of disorders,” said Dr. Lee. “This is especially important for the veteran population who disproportionately suffer from addiction and chronic pain. We are excited to advance focused ultrasound to develop non-pharmacologic treatments for veterans with addiction and chronic pain.”
Tobacco Use Disorder
Smoking remains the leading cause of preventable death in the world, and the total cost of smoking-related illness in the United States is more than $300 billion each year.
This clinical trial (NCT06405074) examines the effect of LIFU neuromodulation on smoking craving and the brain’s response to smoking cues in individuals who smoke cigarettes. Researchers are targeting a portion of the brain called the dorsal anterior insula, which is associated with smoking craving. Up to 44 participants will be included in the study, and about one-third of those have already been enrolled. The participants receive a single session of LIFU and a single session of sham stimulation – or a simulated procedure where physicians do not actually deliver the focused ultrasound – to the dorsal anterior insula. Dr. Lee and her team are examining the effect of LIFU compared to sham on the brain’s response to smoking cue exposure during functional MRI scanning. In addition, researchers will examine the safety and tolerability of LIFU to this brain region.
Chronic Pain
An estimated 100 million Americans have experienced chronic pain, which is associated with an estimated annual cost of $635 billion. Moreover, the most common treatment for chronic pain is pharmaceuticals, which contributed to the opioid use epidemic.
This clinical trial (NCT06906211) targets the posterior region of the insula that is known to be involved in chronic pain processing. A total of 66 participants with chronic back pain will be enrolled in the trial and will receive one session each of LIFU and sham treatment. Researchers will assess safety and tolerability as well as neural response to evoked pain, clinical pain, and pain intensity symptoms.
To date, approximately 20 veterans have been enrolled in this study.
The Complex Patient (Opioid Use Disorder with Chronic Pain and Anxiety)
This clinical trial (NCT06453109) assesses the safety and tolerability of LIFU for individuals with OUD with co-morbid chronic pain and anxiety. This triad is associated with the highest risk of opiate overdose deaths because co-occurrence of the three disorders amplifies the symptoms of each.
Dr. Lee and her team are targeting the anterior insula with LIFU to determine its causal role in pain processing, anxiety, and opiate cue–induced craving. The researchers are also assessing the participants’ heart rate variability and pain threshold before and immediately after LIFU compared with sham.
This trial recently completed enrollment with a total of 20 participants.
Information for Patients
The three clinical trials all follow a similar protocol. Participants will have MRI and CT scans during the screening process. If eligible to continue in the study, they will undergo a single session each of noninvasive focused ultrasound and sham. The smoking and chronic pain studies involve fMRI sessions before and after LIFU/Sham sessions.
The research team completes follow up phone calls with all participants after their study sessions.
If you are a veteran and are interested in learning more about the two trials that are still seeking participants, please contact:
Mary R Lee, MD
202-745-8000, ext. 58128
[email protected]