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Transcranial Pulse Stimulation for Mild Dementia and Aging Well

This study is testing a device called Neurolith Transcranial Pulse Stimulation (TPS) to see if it can improve brain function in people with mild dementia and those who are aging typically. Researchers will apply low-intensity magnetic pulses to specific areas of the brain. The study aims to see how much cognitive function (thinking, memory) and brain structure change after treatment. You might be able to join if you are between 65 and 84 years old, speak English, and are physically mobile. The study will measure success by looking at changes in a score that combines different tests of thinking and memory (ADAS-Cog-Plus-EF&FA Battery Total Score) after four weeks. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is a randomized, sham-controlled study with 20 participants, divided into two groups: 10 typically-aging older adults and 10 patients with mild dementia. Participants will receive either active Neurolith TPS or a sham (inactive) version.
What's involved
You would have a screening visit, a baseline visit with MRI and cognitive tests, 6 treatment visits over two weeks, and a final visit with MRI and cognitive tests. This means about 9 in-person visits over approximately four weeks.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive function will be measured at four weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05910619

Transcranial Pulse Stimulation of the Brain

Recruiting
NAAges 65–84InterventionalTreatment
University of Florida
~20 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:Neurolith Transcranial Pulse Stimulation ActiveNeurolith Transcranial Pulse Stimulation Sham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ADAS-Cog-Plus-EF&FA Battery Total Score
Measured over Four weeks

Conditions

Mild Dementia
Aging Well

Explore related trials

AgingMild dementia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

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

Who to contact

Joseph M Gullett, Ph.D.
[email protected]
352-294-8631
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • ADAS-Cog-Plus-EF&FA Battery Total ScoreFour weeks

    The ADAS-Cog-Plus total score is touted as the gold standard measure for outcomes measurement following anti-dementia interventions18, allows for reliable longitudinal data collection, and provides coverage of cognitive domains including orientation, memory, language, and praxis.