Key Points
- A clinical trial is investigating the safety and feasibility of using low-intensity focused ultrasound to address anxiety and depression.
- The trial is taking place at the Providence Veterans Affairs Healthcare System and is open only to veterans.
- The Foundation is funding a portion of this trial.
A clinical trial is underway investigating the safety and feasibility of using low-intensity focused ultrasound (LIFU) to address anxiety and depression.
Preliminary data show that LIFU may be able to reach deep structures of the brain involved with depression and anxiety that traditional therapies are unable to precisely treat. In this study, investigators will test whether non-ablative LIFU can reversibly modulate brain activity in areas that are connected to depression and anxiety symptoms.
The study (NCT 05147142) is being led by Noah S. Philip, MD, professor of psychiatry and human behavior at the Alpert Medical School of Brown University and Director of Mental Health Research at the Center for Neurorestoration and Neurotechnology at the Providence Veterans Affairs (VA) Healthcare System. It is being administered by the Ocean State Research Institute.
Up to 25 participants who suffer from major depressive disorder with or without anxiety symptoms will be enrolled and complete neurological assessments, including clinical and research neuroimaging, neuropsychological testing, and questionnaires. Physicians will then administer LIFU using the Brainsonix BX Pulsar 1002 device to the target area of the brain (the amygdala) and a control area (the somatosensory cortex) in two different sessions. After each session, participants will undergo thorough assessments for safety and clinical changes.
“The available technologies that we have right now – primarily transcranial magnetic stimulation – stimulate only the outside surface of the brain,” explains Dr. Philip. “But the key areas involved in psychiatric disorders are in the deep regions of the brain where available technologies cannot reach. This is where focused ultrasound comes into play. If the results of this study are positive, the data will serve as a strong foundation for the future development of innovative treatments for a variety of psychiatric disorders.”
To date, the first several participants have been enrolled in the clinical trial. The study is funded by the National Institute of Mental Health, and the Focused Ultrasound Foundation is funding a portion of this clinical trial.
For Patients
At this point, the study is only recruiting veterans with depression. Kindly review the inclusion and exclusion criteria available on clinicaltrials.gov.
If you are interested in learning more about this clinical trial, please contact:
Emily Aiken, MA
(401) 273-7100 ext. 16437
Emily.Aiken@va.gov