By Jill Pease
A University of Florida College of Public Health and Health Professions team is the first in the U.S. to test a new non-invasive device that may improve brain structure and function in adults with Alzheimer’s and mild dementia under a U.S. Food and Drug Administration investigational device exemption.
A team led by Joseph Gullett, Ph.D., an assistant professor in the UF PHHP department of clinical and health psychology, will conduct a randomized clinical trial with the Swiss-made NEUROLITH TPS, a transcranial pulse stimulation device that delivers a low intensity energy wave to key brain regions.
“This is the first study using this device in the United States thus far, and the first randomized clinical trial investigating the device’s effectiveness in Alzheimer’s and/or mild dementia,” said Gullett, a member of the UF Center for Cognitive Aging and Memory Clinical Translational Research. “My hope is that our study can shed light on the potential of this intervention to positively impact thinking and memory and brain health in Alzheimer’s disease.”
The NEUROLITH TPS device, which is being used clinically across Europe, produces a non-invasive shockwave that can impact brain areas typically affected by Alzheimer’s disease, Gullett said. In a European study of patients with mild dementia, the TPS intervention was reported to increase cortical thickness of the brain and improve cognitive performance. The UF study will be the first to use this intervention in a randomized controlled fashion so that the effect on cognitive performance can be investigated more clearly, Gullett said.
The UF study will enroll 10 older adults with mild dementia due to suspected Alzheimer’s disease and 10 typically-aging older adults. Participants will be placed randomly in one of two groups. In one, participants will receive six transcranial pulse stimulation sessions over two weeks. In the second group, the research team will replicate the same procedures, but no transcranial pulse will be delivered. The team will collect data from participants’ MRI scans pre- and post-treatment, cognitive tests and various other important disease-related data. In addition, researchers will ask participants to complete a functional outcomes questionnaire every three months for one year.
“Once the data are unblinded and the group randomization is revealed, we will be able to determine if those who received the TPS demonstrate any thinking and memory changes as well as any lasting changes in their functional abilities in the home, such as ability to cook meals, manage medications and so forth,” Gullett said.
With results from this pilot study, he hopes to expand the study to a larger group of participants over a longer period of time and with advanced outcome measures.
“If it is effective at improving patient outcomes, I hope to improve the process required to use this device so that it can be simplified and normalized into a repeatable and reliable treatment,” Gullett said.