Pulsed Electromagnetic Field Treatment With Dementia Patients

NCT ID
NCT06862557
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Herrick Medical LLC
Conditions
Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study

Enrollment: 48 participants (Estimated).

What is being studied

  • Device: ECHS AD Device

Who may be eligible

Ages
50 Years to 100 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Florida, United States: 1

Sample of listed locations

  • University of Miami — Boca Raton, Florida, 334233, United States — Recruiting

Study details

Start date
April 1, 2025
Primary completion date
April 30, 2027
Completion date
September 30, 2027
First posted
March 6, 2025
Collaborators
University of Miami

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06862557
Registry last updated
September 17, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT06862557 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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