NCT05910619 Transcranial Pulse Stimulation of the Brain
| NCT ID | NCT05910619 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Mild Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2026-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-02-16 with a primary completion date of 2026-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Joseph Gullett, Ph.D.
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05910619 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 84 Years, studying Mild Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05910619 currently recruiting?
Yes, NCT05910619 is actively recruiting participants. Contact the research team at gullettj@phhp.ufl.edu for enrollment information.
Where is the NCT05910619 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05910619 clinical trial?
NCT05910619 is sponsored by University of Florida. The principal investigator is Joseph Gullett, Ph.D. at University of Florida. The trial plans to enroll 20 participants.