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Transcranial Pulse Stimulation of the Brain

NCT05910619 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Mild Dementia
  • Aging Well

Interventions

DEVICE

Neurolith 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.

DEVICE

Neurolith 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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Joseph Gullett, Ph.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2026-09-16
Completion
2026-12-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05910619 on ClinicalTrials.gov