Key Points
- Results from an Alzheimer’s clinical trial testing low-intensity focused ultrasound (LIFU) neuromodulation have now been published.
- Repeated LIFU to the prefrontal cortex enhanced neural connectivity and improved memory.
Repeated Neuromodulation with Low-Intensity Focused Ultrasound in Patients with Alzheimer’s Disease
Ten participants with Alzheimer’s disease were enrolled in a pilot clinical trial in Korea (KCT0008169) that used the Neurosona device to repeatedly apply low-intensity focused ultrasound (LIFU) neuromodulation to the left dorsolateral prefrontal cortex. The five men and five women with a mean age of 72.4 years had a baseline Mini-Mental State Examination 2nd Edition (MMSE-2) score of 20. MMSE-2 is a brief assessment of cognitive function in adults in which scores less than 24 are considered abnormal; the range of 18–23 is rated as mild cognitive impairment.
Led by Yong-An Chung, MD, PhD (nuclear medicine), and In-Uk Song, MD (neurology), at Incheon St. Mary’s Hospital in Seoul, South Korea, the team used Neurosona’s NS-US200 device under real-time, image-guided neuronavigation for the research study. The NA-US200 device is connected to each participant via headgear, and a motion tracking system provides additional target alignment.
Over a three-week period, participants received six sessions of LIFU to their left dorsolateral prefrontal cortex while continuing their standard pharmacologic therapies. Neuropsychological tests and resting-state functional MRI scans were performed at baseline and again eight weeks after the last treatment session.
The results were encouraging: researchers found statistically significant improvements in both memory performance (p = 0.02) and functional connectivity in the brain (corrected p < 0.05). No adverse events were reported.
After further optimizing stimulation parameters and the treatment protocol, the research team recommended conducting randomized, sham-controlled trials to investigate LIFU as a supplemental or alternative treatment option for patients with Alzheimer’s disease.
“Next we are planning a randomized controlled trial for dementia patients to begin in the near future, and we are in close contact with the Korean Food and Drug Administration,” said Dr. Chung. “In addition, an exploratory study on Parkinson’s disease is also being planned.”
See the Journal of Alzheimer’s Disease
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