Using Transcranial Pulse Stimulation to Enhance Brain Function
Transcranial Pulse Stimulation of the Brain in Older Adults With and Without Mild Dementia
NA · University of Florida · NCT05910619
This study is testing if a new brain stimulation technique can improve thinking and memory in older adults, including those with mild dementia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 84 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05910619 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial pulse stimulation (TPS) on cognitive and neural function in older adults, including those with mild dementia. Participants will be randomly assigned to receive either active TPS or a sham treatment in a controlled trial. The study will involve pre- and post-intervention assessments using MRI, blood tests, and neurocognitive evaluations to measure changes in brain function and structure. A total of 20 participants, 10 with mild dementia and 10 typically-aging adults, will undergo thrice-weekly TPS sessions over two weeks.
Who should consider this trial
Good fit: Ideal candidates are English-speaking men and women aged 65 to 84, either typically aging or with mild dementia.
Not a fit: Patients with neurological disorders unrelated to dementia or those with greater-than-mild dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cognitive function and quality of life for patients with mild dementia and typical aging.
How similar studies have performed: While TPS is a novel approach, similar studies exploring non-invasive brain stimulation techniques have shown promising results in cognitive enhancement.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Joseph Gullett, Ph.D. — University of Florida
- Study coordinator: Joseph M Gullett, Ph.D.
- Email: gullettj@phhp.ufl.edu
- Phone: 352-294-8631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Dementia, Aging Well, Typical Aging, Transcranial Pulse Stimulation