RecruitingNot ApplicableNCT05910619

Transcranial Pulse Stimulation of the Brain

Transcranial Pulse Stimulation of the Brain in Older Adults With and Without Mild Dementia

Sponsor

University of Florida

Enrollment

20 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Mild Dementia Aging Well

Summary

This study will investigate transcranial pulse stimulation (TPS) as a method of enhancing cognitive and neural function. The study team will apply this low intensity, magnetically pulse technology to key brain regions in a randomized, sham-controlled trial (RCT). The study will determine the magnitude of changes in cognitive function and brain function and structure between a pre- and post-stimulation among 10 typically-aging older adults and 10 patients with mild dementia.

Eligibility

Min Age: 65 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Neurolith Transcranial Pulse Stimulation Active and a medical device called Neurolith Transcranial Pulse Stimulation Sham for people with aging well and mild dementia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years to 84 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENeurolith Transcranial Pulse Stimulation Active

5hz (200-300 milliseconds) stimulation pulses transcranial pulse stimulation (TPS) will be applied to each of the following five regions twice per session in sequential order with the specified stimulation parameters: left dorsolateral prefrontal cortex and inferior frontal cortex extending to Broca's area (2x800 pulses), right dorsolateral prefrontal cortex and inferior frontal cortex extending to Broca's area (2x800 pulses; ROI volume \~136/164 cms), the left lateral parietal cortex extending to Wernicke's area (2x400 pulses; ROI volume \~122/147 cms), the right lateral parietal cortex extending to Wernicke's area (2x400 pulses; ROI volume \~122/147 cms), and the extended precuneus cortex (2x600 pulses; ROI volume 66/92 cms). With a repetition time of 5hz (0.00333 seconds) per pulse at a total of 6,000 pulses per participant, the duration of stimulation is about 20 minutes, not including transition time between ROI localization.

DEVICENeurolith Transcranial Pulse Stimulation Sham

The intervention procedure described in the Active condition above will also be repeated in participants randomized to the Sham procedure, with the exception of the insertion of a lens over the device by the interventionist to prevent stimulation from reaching the brain.

Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05910619

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