Pulsed Electromagnetic Field Treatment for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Magdalena Tolea, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Herrick Medical LLC

Must be taking: Cholinesterase inhibitors, Memantine

Must not be taking: Seizure threshold reducers, Anti-amyloid antibodies

Disqualifiers: Epilepsy, Parkinson's, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 17 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pulsed electromagnetic field treatment to determine its effectiveness in slowing the progression of Alzheimer's disease and related dementias. Participants will use a special device (ECHS AD Device) at home three times a day for 15 minutes over four months. The main goal is to observe changes in memory and thinking skills. The trial seeks individuals diagnosed with mild to moderate Alzheimer's or similar conditions, such as Lewy body or vascular dementia, who can follow the treatment routine. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for Alzheimer's and related dementias.

Will I have to stop taking my current medications?

If you are taking a cholinesterase inhibitor or memantine, you must have been on a stable dose for at least 60 days before the trial and continue that dose during the study. If you are taking anti-amyloid monoclonal antibodies, you must have stopped at least 3 months before the trial. The protocol does not specify other medication restrictions, but you cannot take medications that lower the seizure threshold.

What prior data suggests that this device is safe for Alzheimer's patients?

Research on the ECHS AD device shows it is generally well-tolerated. In past studies, people with Alzheimer's disease used this pulsed electromagnetic field treatment without major issues. The FDA has already approved some devices with similar technology for other conditions, supporting evidence of safety. However, while the device seems promising, detailed information about side effects specific to Alzheimer's treatment remains limited. Reports so far suggest it is safe, but further research could help confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Alzheimer's disease, which often include medications like cholinesterase inhibitors and memantine aimed at managing symptoms, the ECHS AD device offers a unique approach. This treatment uses pulsed electromagnetic fields to potentially alter brain activity, aiming to target the disease's underlying mechanisms rather than just alleviate symptoms. Researchers are excited about the ECHS AD device because it represents a non-drug alternative that could open new avenues for managing Alzheimer's, with the potential for fewer side effects and novel therapeutic benefits.

What evidence suggests that the ECHS AD Device is effective for Alzheimer's Disease?

Research has shown that treatments using electromagnetic fields, such as the ECHS AD Device, can improve thinking and memory in people with Alzheimer's. Early studies suggest these treatments may slow the disease in mild to moderate cases. The ECHS AD Device, which trial participants will receive, uses pulsed electromagnetic fields believed to enhance brain cell function by boosting energy. While detailed data is still being gathered, early signs are promising for supporting brain health. This treatment offers hope for managing Alzheimer's symptoms more effectively. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate Alzheimer's Disease. Participants will use the ECHS AD device at home, three times a day for 15 minutes over a period of 120 days. The study requires follow-up for 9 months post-treatment.

Inclusion Criteria

My doctor says I am fit to join the study.

At least an eighth grade of educational achievement

MMSE score between 16 and 26

Exclusion Criteria

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

I am on medication that increases my risk of seizures.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pulsed electromagnetic field treatment at home three times a day for 15 minutes over 120 days

17 weeks

Home-based treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

What Are the Treatments Tested in This Trial?

Interventions

• ECHS AD Device

Trial Overview

The trial is testing the ECHS AD pulsed electromagnetic treatment device on slowing disease progression in Alzheimer's patients. It's an open label pilot study where all enrolled patients receive active devices and self-administer treatment.

How Is the Trial Designed?

Group I: Active ECHS AD device Experimental Treatment 1 Intervention

Experimental intervention arm

Who Is Running the Clinical Trial?

Herrick Medical LLC

Lead Sponsor

Trials

3

Recruited

140+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Transcranial electrical stimulation (tES) methods, including tDCS, tACS, tRNS, and tPCS, were effective in reversing cognitive impairments caused by beta-amyloid in a rat model of Alzheimer's disease, indicating potential therapeutic benefits.

Among the different stimulation paradigms, tRNS showed the most significant improvement in memory performance, suggesting that various tES techniques could be viable options for treating cognitive deficits in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ameliorative Effects of Different Transcranial Electrical Stimulation Paradigms on the Novel Object Recognition Task in a Rat Model of Alzheimer Disease. Zarifkar, AH., Zarifkar, A., Nami, M., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05295615

NCT05295615 | Pulsed Electromagnetic Field Treatment In ...

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 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05295615?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Herrick%20Medical%20LLC%22))&rank=2

Pulsed Electromagnetic Field Treatment In Patients With ...

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 ...

3.

withpower.com

withpower.com/trial/phase-alzheimer-disease-2-2025-10c4f

Pulsed Electromagnetic Field Treatment for Alzheimer's ...

Research shows that electromagnetic field (EMF) treatments, similar to the ECHS AD Device, have been effective in improving cognitive function in Alzheimer's ...

4.

trialx.com

trialx.com/clinical-trials/listings/296982/pulsed-electromagnetic-field-treatment-with-dementia-patients/

Pulsed Electromagnetic Field Treatment With Dementia ...

An open label pilot study in mild to moderate AD/ADRD patients to assess the effects of treatment with ECHS AD/ADRD pulsed electromagnetic ...

5.

lbda.org

lbda.org/pulsed-electromagnetic-field-treatment-with-dementia-patients/

Pulsed Electromagnetic Field Treatment with Dementia ...

The purpose of this study is to assess the effects of treatment with pulsed electromagnetic treatment device on disease progression for those individuals living ...