Pulsed electromagnetic field treatment for dementia patients
Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study
This study is testing a pulsed electromagnetic device to see if it can help people with mild to moderate Alzheimer's disease improve their thinking and memory over 120 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Herrick Medical LLC Industry-sponsored |
| Locations | 1 site (Boca Raton, Florida) |
| Trial ID | NCT06862557 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of a pulsed electromagnetic treatment device on patients with mild to moderate Alzheimer's disease and related dementias. Participants will use the device at home for 15 minutes, three times a day, over a period of 120 days. The primary outcome measure will be the Alzheimer's Disease Assessment Scale-Cognitive Subscale, with follow-up assessments conducted for nine months post-treatment. The study aims to evaluate the potential impact of this non-invasive treatment on disease progression.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older diagnosed with mild to moderate Alzheimer's disease or related dementias.
Not a fit: Patients who lack the capacity to consent or have severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could slow the progression of dementia symptoms in affected patients.
How similar studies have performed: While this approach is relatively novel, similar studies exploring non-invasive treatments for dementia have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline. 3\. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician Exclusion Criteria: 1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent 2. The patient does not have a study partner who would be available for interview 3. History of epileptic seizures or epilepsy 4. Has Frontotemporal Dementia 5. Currently taking medication that lowers the seizure threshold, excluding blood thinners 6. Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit). 7. Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study 8. Severe agitation that would interfere with study procedures 9. Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation 10. Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of \>1 week hospitalization) within 4 weeks 11. Head anatomy that interferes with the fit of the treatment device 12. Participation in another clinical trial within the previous 30 days 13. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth 14. Criteria to exclude participants from the blood draw study: Any condition that may significantly increase risks associated with blood draws
Where this trial is running
Boca Raton, Florida
- University of Miami — Boca Raton, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Magdalena Tolea, PhD
- Email: mit38@med.miami.edu
- Phone: 561-869-6810
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.