Pulsed Electromagnetic Field Treatment With Dementia Patients

Last updated: May 15, 2025
Sponsor: Herrick Medical LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Memory Loss

Vascular Dementia

Treatment

ECHS AD Device

Clinical Study ID

NCT06862557
HM004
  • Ages 50-100
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD includingAlzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a globalCDR of 0.5 or 1 at baseline.

  2. At least an eighth grade of educational achievement 4. If female, post-menopausal.

  3. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent orhaving a surrogate (e.g., spouse, family member) capable of providing consent ifparticipant lacks consent capacity 7. Able and willing to comply with the protocol

  4. If the participant is receiving a cholinesterase inhibitor and/or memantine, suchmedication has been prescribed for at least 3 months prior to screening and the doseis stable for at least 60 days prior to screening (that dose needs to be maintainedthroughout the period of this study) 10. Physical clearance for study participationas evaluated by the clinician

Exclusion

Exclusion Criteria:

  1. The patient lacks capacity to consent to study participation and no surrogate isavailable 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 bloodthinners

  6. Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed iftermination of treatment occurred at least 3 months prior to the baseline visit).

  7. Presence of depression, bipolar disorder, a psychotic disorder, or any otherneurological or psychiatric condition (whether now or in the past), which theInvestigator 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 Manualof Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more thanone year and or in remission less than 3 years) or severe sleep deprivation

  10. Major surgery (defined as any major abdominal, vascular or thoracic surgeryrequiring 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 stimulatorsand 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 Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: ECHS AD Device
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • University of Miami

    Boca Raton, Florida 334233
    United States

    Active - Recruiting

  • Hackensack Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.