48 Participants Needed

Pulsed Electromagnetic Field Treatment for Alzheimer's Disease

Recruiting at 1 trial location
MP
MT
Overseen ByMagdalena Tolea, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Herrick Medical LLC
Must be taking: Cholinesterase inhibitors, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.56789

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.510111213

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
See 7 more

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
See 7 more

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
1Treatment groups
Experimental Treatment
Group I: Active ECHS AD deviceExperimental Treatment1 Intervention
Experimental intervention arm

Find a Clinic Near You

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.
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

Ameliorative Effects of Different Transcranial Electrical Stimulation Paradigms on the Novel Object Recognition Task in a Rat Model of Alzheimer Disease. [2022]
Effects of short- and long-term neurostimulation (tDCS) on Alzheimer's disease patients: two randomized studies. [2022]
Analyzing the Effect of Weak External Transcranial Magnetic Stimulation on the Primary Dominant Frequencies of Alzheimer Patients Brain by Using MEG Recordings. [2021]
Effects of electromagnetic fields emitted by GSM phones on working memory: a meta-analysis. [2018]
Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. [2018]
6.United Arab Emiratespubmed.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]
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]
A Pulsed Electromagnetic Field Protects against Glutamate-Induced Excitotoxicity by Modulating the Endocannabinoid System in HT22 Cells. [2020]
Cytoskeletal Remodeling and Gap Junction Translocation Mediates Blood-Brain Barrier Disruption by Non-invasive Low-Voltage Pulsed Electric Fields. [2023]
Low frequency vortex magnetic field reduces amyloid β aggregation, increase cell viability and protect from amyloid β toxicity. [2021]
11.United Statespubmed.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 Emiratespubmed.ncbi.nlm.nih.gov
Electromagnetic Field in Alzheimer's Disease: A Literature Review of Recent Preclinical and Clinical Studies. [2021]
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]
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