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Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease

NCT02958930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-04-23

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and initial efficacy of Transcranial Electromagnetic Treatment (TEMT) in patients with mild/moderate Alzheimer's Disease. Throughout a 2-month treatment period, patients will be evaluated for cognitive performance, brain energy utilization, functional brain imaging, and blood/cerebrospinal fluid (CSF) markers for Alzheimer's Disease. Since all patients will receive TEMT, each patient's baseline measurements will serve as their own control for any treatment effects.

Conditions

  • Alzheimer Disease
  • Alzheimer Disease, Late Onset

Interventions

DEVICE

MemorEM 1000

The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized antennas in the head cap worn by the subject. The device provides global RF treatment to the entire forebrain, including deep brain areas. For each of the 60 days of in-home treatment, two one-hour treatment will be given (early morning and late afternoon). Each treatment will be administered by the patient's caregiver, who will position the device on the patient's head and monitor treatment.

Sponsors & Collaborators

  • Byrd Alzheimer's Institute, University of South Florida

    collaborator UNKNOWN

  • University Diagnostic Institute, Tampa

    collaborator UNKNOWN

  • Invicro, Boston

    collaborator UNKNOWN

  • Left Coast Engineering, Escondido

    collaborator UNKNOWN

  • NeuroEM Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Amanda Smith, MD · Byrd Alzheimer's Institute, University of South Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
63 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-01-04
Completion
2019-01-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958930 on ClinicalTrials.gov