Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease

September 14, 2026 updated by: Herrick Medical LLC

Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Controlled Pilot Study

An open label pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD 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 points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 50 years
  2. Patients diagnosed with mild to moderate Alzheimer's Dementia defi
  3. At least an eighth grade of educational achievement
  4. If female, post-menopausal.
  5. MMSE score between 16 and 26
  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)
  9. Spouse, family member or professional caregiver agree and are capable of taking care of the participation of the patient in the study (answering questions regarding the patient's condition, assuming responsibility for medication, and applying and supervising the daily PEMF treatments)
  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. History of epileptic seizures or epilepsy
  3. Currently taking medication that lowers the seizure threshold
  4. 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
  5. Severe agitation that would interfere with study procedures
  6. 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
  7. 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
  8. Head anatomy that interferes with the fit of the treatment device
  9. Participation in another clinical trial within the previous 30 days
  10. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active ECHS AD device
Experimental intervention arm
Device: ECHS AD Device
Pulsed electromagnetic therapy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time Frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Mini-Mental Status Exam (MMSE)
Time Frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Global Deterioration questionnaire
Time Frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Quality of Life Scale
Time Frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herrick Medical LLC

Collaborators

Hackensack Meridian Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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