Transcranial Pulse Stimulation for Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether transcranial pulse stimulation (TPS) can enhance brain function and cognitive abilities in individuals with mild dementia. TPS involves applying gentle magnetic pulses to specific brain areas to assess improvements in memory and thinking skills. Participants will be divided into two groups: one receiving actual TPS (Neurolith Transcranial Pulse Stimulation Active) and the other receiving a placebo version (Neurolith Transcranial Pulse Stimulation Sham) to compare the effects. Suitable candidates include English-speaking adults aged 65 to 84 who can walk two blocks without stopping and have no serious balance issues or history of major falls. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in dementia treatment.
Do I need to stop taking my current medications for the trial?
The trial requires that you avoid medications with cognitive side effects or strong anticholinergic effects. You should be stable on any recently changed medications for at least four weeks before starting the study. Your medications will be reviewed to identify any that might interfere with the trial.
What prior data suggests that transcranial pulse stimulation is safe for enhancing cognitive and neural function?
Research has shown that transcranial pulse stimulation (TPS) is generally well-tolerated. In some studies, TPS has been safely used even in individuals with moderate to severe Alzheimer's disease. One study found that TPS improved brain function without major side effects. Another study noted that TPS helped reduce symptoms related to brain disorders. The Neurolith system, used for TPS, received approval in Europe in 2018 for treating Alzheimer's, indicating likely safety. However, further research is needed to understand the long-term effects.12345
Why are researchers excited about this trial?
Researchers are excited about Transcranial Pulse Stimulation (TPS) for dementia because it offers a non-invasive approach that targets brain networks directly, unlike traditional medications that often involve systemic effects and side effects. This treatment uses focused pulsed stimulation to engage specific regions of the brain's default mode network, potentially improving cognitive function more directly and precisely. Unlike the standard care, which typically involves medications like cholinesterase inhibitors or memantine, TPS may provide a novel mechanism of action by physically stimulating brain activity, offering hope for improved outcomes in a condition with limited treatment advancements.
What evidence suggests that transcranial pulse stimulation is effective for dementia?
Research shows that transcranial pulse stimulation (TPS) can help reduce symptoms in people with dementia. This trial will divide participants into two groups: one receiving active TPS and the other receiving sham TPS. Earlier studies found that active TPS lowered mood and behavior symptoms by up to 23.9 points on a specific rating scale. Additionally, reports indicate that memory and thinking test scores improved by about 3.91 points three months after treatment. These findings suggest TPS could be a promising option for improving brain function and reducing symptoms in mild dementia. More research is needed, but the initial results are encouraging.13567
Who Is on the Research Team?
Joseph M Gullett, PhD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for English-speaking men and women aged 65-84 who are physically mobile without major falls or balance issues. It includes healthy older adults and those with mild dementia, as determined by specific cognitive tests (TICS and MoCA). Exclusions include severe medical conditions, certain medication use, history of brain infections or neurological disorders, MRI contraindications like metal implants, left-handedness/ambidextrousness due to atypical brain function lateralization.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo pre-intervention multi-modal MRI, blood draw, and neurocognitive evaluation
Treatment
Participants receive thrice-weekly transcranial pulse stimulation (TPS) for two weeks
Post-intervention Assessment
Participants undergo post-intervention MRI, blood draw, and neurocognitive evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a no-contact period and quarterly phone surveys for one year
What Are the Treatments Tested in This Trial?
Interventions
- Neurolith Transcranial Pulse Stimulation Active
- Neurolith Transcranial Pulse Stimulation Sham
Neurolith Transcranial Pulse Stimulation Active is already approved in European Union for the following indications:
- Alzheimer's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor