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Pulsed Electromagnetic Field Treatment With Dementia Patients | Clinical Trials | Clareo Health

RECRUITINGNA

Pulsed Electromagnetic Field Treatment With Dementia Patients

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

NCT06862557•Herrick Medical LLC

Summary

An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.

Eligibility

Age

50 - 100 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

University of Miami

Boca Raton, Florida, United States

Key Dates

Start Date

April 1, 2025

Primary Completion Date

April 30, 2026

Completion Date

September 30, 2026

Last Updated

May 18, 2025

Enrollment

ESTIMATED participants

Conditions

Alzheimer's DiseaseLewy Body DementiaVascular Dementia

Interventions

ECHS AD Device

DEVICE

Contacts

Magdalena Tolea, PhD

CONTACT

561-869-6810 mit38@med.miami.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Pulsed Electromagnetic Field Treatment With Dementia Patients

Inclusion Criteria

Exclusion Criteria

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