Transcranial Pulse Stimulation of the Brain

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05910619
Status
Recruiting
Apply to this trial

Conditions

  • Aging Well
  • Mild Dementia

Eligibility Criteria

Sex
ALL
Age
65 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Neurolith Transcranial Pulse Stimulation Active — DEVICE
    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.
  • Neurolith Transcranial Pulse Stimulation Sham — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
Apr 2026
Primary completion
Sep 16, 2026
Completion
Dec 7, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active brain stimulation
    These participants will receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description.
  • Sham Comparator: Sham brain stimulation
    These participants will also receive focused TPS (pulsed stimulation) of the specified default mode network regions as specified in the detailed study description, though the device will be set to "Sham" in a blinded fashion by the biostatistician by placing an air pouch in the device hand piece.

Primary Outcome Measure

ADAS-Cog-Plus-EF&FA Battery Total Score [ Time Frame: Four weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Joseph Gullett, Ph.D.
[email protected]
352-294-8631
Joseph M Gullett, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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