Safety and efficacy of pulsed electromagnetic fields treatment tracked in patients with mild to moderate Alzheimer’s disease in EVOKE study

Hackensack University Medical Center is studying the effects of pulsed electromagnetic fields (PEMF) as a treatment for Alzheimer’s disease in the EVOKE study. The randomized, controlled pilot study focuses on the efficacy and safety of PEMF for patients with mild to moderate Alzheimer’s disease.

The biological effectiveness of PEMF signals (a small range) have been well documented over the last century for effectiveness and safety. The FDA has cleared PEMF devices for treating pain, edema, osteoarthritis and plantar fasciitis, and PEMF is reimbursed by Medicare for treating chronic wounds.

PEMF also is shown to improve outcomes in both acute and chronic neurological diseases, but only one small pilot trial in the clinical setting has focused on the treatment’s use in patients with Alzheimer’s disease.

The EVOKE protocol is designed to assess whether the ECHS — Electro Cellular Healthcare Solutions — Alzheimer’s disease device can demonstrate safety and efficacy in a double-blinded pilot trial of 48 patients. The pilot study includes two treatment arms, one active and one placebo. The placebo treatment arm uses an identical device that does not deliver therapy but is indistinguishable from the active unit without specialized equipment.

During the study, patients will be randomized and treated for up to 120 days. Following baseline assessment, participants will be assessed every 30 days during that period.

Patients will enter a nine-month, post-treatment follow-up period to assess any possibly related AEs and treatment-related effects. Patients will be assessed every three months during the post-treatment follow-up period.

The researchers intend to have two arms with two cohorts in this pilot study, then power a larger RCT to assess efficacy for the desired endpoints.

Learn more about innovative neurological care at Hackensack University Medical Center.