Recruiting

Transcranial Pulse StimulationTranscranial Pulse Stimulation of the Brain

Sponsor:

University of Florida

Code:

NCT05910619

Conditions

Mild Dementia

Aging Well

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Neurolith Transcranial Pulse Stimulation Active

Neurolith Transcranial Pulse Stimulation Sham

Study Details

Brief 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

Study ID

NCT05910619

Start date

Feb 16, 2024

Status verified date

Oct, 2026

Completion date

May 7, 2027

Anticipated

Primary completion date

Mar 16, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Men and women
Age: 65 to 84 years
English speaking
Physically mobile with no history of balance difficulties or major falls
For the typically-aging older adult group, phone screening performance on the TICS must be greater than or equal to 33 points, and cognitive performance of 26 points or greater on the MoCA and a Sum of Boxes score of 0 on the Clinical Dementia Rating scale administered to the participant's informant at the initial visit
For the Mild dementia group, phone screening performance on the TICS must be between 21 and 32 points, and subsequent cognitive performance of on the MoCA must be <23 with a CDR Sum of Boxes score between 4.5 and 9.0 as administered to the participants known informant at the initial visit.

Exclusion Criteria:

Neurological disorders unrelated to dementia / AD (e.g., Parkinson's disease, stroke, seizures, traumatic brain injury)
Evidence of greater-than-mild dementia/AD (based on informant CDR Sum of Boxes score greater than 9.0 or MoCA <10)
Past opportunistic brain infection
Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis or severe major depression and/or suicidality) or any history of agitation and/or delirium
Unstable (e.g., cancer other than basal cell skin) and chronic (e.g., diabetes mellitus) medical conditions
MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI and TPS)
Physical impairment precluding motor response or lying still for one hour and inability to walk two blocks without stopping or without balance difficulties
Drug exclusions include those medications that are known to have cognitively sedating or altering effects as well medications with a strong anticholinergic burden or CNS effects. Participants should be stable on any recently altered medications/dosages for at least four weeks prior to beginning the study. Medications will be reviewed during the interview for the purpose of identification of contraindicated pharmacological agents with common cognitive side-effects
Other history of medical conditions that may increase risk of cerebrovascular events, including prior heart attack, cardiac arrhythmia such as atrial fibrillation
Hearing or vision deficits that will not allow for reliable standardized cognitive assessment; i.e. colorblindness, inability to hear through headphones (with or without hearing aids), macular degeneration or other significant diseases that cause severe loss of vision. If vision is corrected with lenses to appropriate levels, then participant will be eligible
Left-handedness and ambidextrousness, as these individuals have a higher percentage rate of atypical functional lateralization for brain functions, which would significantly interfere with interpretability of brain data
Hemophilia or other blood clotting disorders or thrombosis
Corticosteroid treatment within the last six weeks before the first treatment

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joseph M Gullett, Ph.D.

352-294-8631 gullettj@phhp.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Joseph Gullett, Ph.D.

352-294-8631 gullettj@phhp.ufl.edu

Principal Investigator:

Joseph M Gullett, PhD

More Information

Sponsor

University of Florida

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

Mild Dementia
Typical Aging
Transcranial Pulse Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Florida on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.