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NCT06862557Recruiting

Pulsed Electromagnetic Field Treatment With Dementia Patients

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

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
48 (estimated)
First submitted
2 Mar 2025
Start date
1 Apr 2025
Primary completion date
30 Apr 2027
Lead sponsor
Herrick Medical LLC
NCT number
NCT06862557

What you commit to

  • Study type: Interventional
  • Planned participants: 48
  • From 1 Apr 2025 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking medication that lowers the seizure threshold, excluding blood thinners
  • 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).
  • 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
  • Participation in another clinical trial within the previous 30 days
  • Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth

Other illness

  • History of epileptic seizures or epilepsy
  • Has Frontotemporal Dementia
  • 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
  • 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
  • Criteria to exclude participants from the blood draw study:
    • Any condition that may significantly increase risks associated with blood draws

Other

  • The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
  • The patient does not have a study partner who would be available for interview
  • Severe agitation that would interfere with study procedures
  • Head anatomy that interferes with the fit of the treatment device

Who the study is looking for

  • 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

Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
Boca RatonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.