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

Trial Summary

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 data supports the effectiveness of the ECHS AD Device treatment for Alzheimer's Disease?

Research shows that electromagnetic field (EMF) treatments, similar to the ECHS AD Device, have been effective in improving cognitive function in Alzheimer's disease models and are considered safe. Additionally, non-invasive brain stimulation techniques, like transcranial electrical stimulation, have shown promise in treating cognitive impairments associated with Alzheimer's. ^{1 2 3 4 5}

Is Pulsed Electromagnetic Field Treatment safe for humans?

Research suggests that Pulsed Electromagnetic Field (PEMF) treatment is generally safe for humans, with studies showing no harmful effects on general health or cognitive function. Some studies even report beneficial effects on brain function, and there is no evidence linking PEMF exposure to an increased risk of cancer. ^{5 6 7 8 9}

How does the ECHS AD Device treatment differ from other Alzheimer's treatments?

The ECHS AD Device uses pulsed electromagnetic fields (PEMF) to treat Alzheimer's, which is unique because it targets the disease by reducing amyloid-beta protein aggregation in the brain, a key factor in Alzheimer's progression. Unlike traditional treatments that only manage symptoms, this non-invasive approach aims to address the underlying disease process and improve cognitive function. ^{5 10 11 12 13}

What is the purpose of this trial?

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Iran 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. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Effects of short- and long-term neurostimulation (tDCS) on Alzheimer's disease patients: two randomized studies. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Analyzing the Effect of Weak External Transcranial Magnetic Stimulation on the Primary Dominant Frequencies of Alzheimer Patients Brain by Using MEG Recordings. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effects of electromagnetic fields emitted by GSM phones on working memory: a meta-analysis. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. [2018]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Low Intensity Electromagnetic Fields Act via Voltage-Gated Calcium Channel (VGCC) Activation to Cause Very Early Onset Alzheimer's Disease: 18 Distinct Types of Evidence. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Induced Neurodifferentiation of hBM-MSCs through Activation of the ERK/CREB Pathway via Pulsed Electromagnetic Fields and Physical Stimulation Promotes Neurogenesis in Cerebral Ischemic Models. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Pulsed Electromagnetic Field Protects against Glutamate-Induced Excitotoxicity by Modulating the Endocannabinoid System in HT22 Cells. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Cytoskeletal Remodeling and Gap Junction Translocation Mediates Blood-Brain Barrier Disruption by Non-invasive Low-Voltage Pulsed Electric Fields. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Low frequency vortex magnetic field reduces amyloid β aggregation, increase cell viability and protect from amyloid β toxicity. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Numerical Analysis and Design of an EMF Birdcage Wearable Device for the Treatment of Alzheimer's Disease: A Feasibility Study. [2022]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Electromagnetic Field in Alzheimer's Disease: A Literature Review of Recent Preclinical and Clinical Studies. [2021]

13. Scotland pubmed.ncbi.nlm.nih.gov

Peripheral pulsed electromagnetic fields may reduce the placebo effect in migraine patients that do not respond to the sham intervention in a randomized, placebo-controlled, double-blind, cross-over clinical trial. [2012]