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Recruiting NCT06862557

Pulsed Electromagnetic Field Treatment With Dementia Patients

No phase Interventional Alzheimer's Disease Lewy Body Dementia Vascular Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECHS AD Device.
Who it may be relevant to
Registry conditions: Alzheimer's Disease, Lewy Body Dementia, Vascular Dementia. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study

Overview

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.

Interventions

  • Device ECHS AD Device
    Pulsed electromagnetic therapy device

Primary outcome measures

  • The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [Time frame: Change between day 0, and 45, 90, 135, 180 days]
Secondary outcome measures (5)
  • Mini-Mental Status Exam (MMSE) [Time frame: Change between day 0, and 45, 90, 135, 180 days]
  • Quality of Life Scale [Time frame: Change between day 0, and 45, 90, 135, 180 days]
  • Global Deterioration questionnaire [Time frame: Change between day 0, and 45, 90, 135, 180 days]
  • Side-Effects Questionnaire [Time frame: Change between day 0, and 45, 90, 135, 180 days]
  • Clinical Dementia Rating (CDR) sum of boxes (CDR-SB) [Time frame: Change between day 0, and 90, 180 days]

Eligibility criteria

Inclusion criteria

1\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.

3\. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician

Exclusion criteria

  • The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
  • The patient does not have a study partner who would be available for interview
  • History of epileptic seizures or epilepsy
  • Has Frontotemporal Dementia
  • Currently taking medication that lowers the seizure threshold, excluding blood thinners
  • Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit).
  • 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
  • Severe agitation that would interfere with study procedures
  • 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
  • Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of >1 week hospitalization) within 4 weeks
  • Head anatomy that interferes with the fit of the treatment device
  • Participation in another clinical trial within the previous 30 days
  • Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
  • Criteria to exclude participants from the blood draw study:

Any condition that may significantly increase risks associated with blood draws

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Boca Raton

Identifiers

NCT: NCT06862557 · HM004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗