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NCT Number: NCT06862557

Pulsed Electromagnetic Field Treatment With Dementia Patients

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.

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Key information

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Boca Raton, Florida, 334233, United States

Location status: Recruiting

Location contact

James Galvin, MD

SUB_INVESTIGATOR

Magdalena Tolea, PhD

CONTACT

[email protected]

561-869-6810

Magdelena Tolea, PhD

PRINCIPAL_INVESTIGATOR

Marcia Walker, APRN

SUB_INVESTIGATOR

Nicole Mendez, APRN

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Treatment and study plan

ECHS AD Device

Device

Pulsed electromagnetic therapy device

Primary outcomes

  1. The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

    Time frame: Change between day 0, and 45, 90, 135, 180 days

    Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.

Secondary outcomes

  1. Mini-Mental Status Exam (MMSE)

    Time frame: Change between day 0, and 45, 90, 135, 180 days

    Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity

  2. Quality of Life Scale

    Time frame: Change between day 0, and 45, 90, 135, 180 days

    Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity

  3. Global Deterioration questionnaire

    Time frame: Change between day 0, and 45, 90, 135, 180 days

    Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity

  4. Side-Effects Questionnaire

    Time frame: Change between day 0, and 45, 90, 135, 180 days

    Self-report of side-effects

  5. Clinical Dementia Rating (CDR) sum of boxes (CDR-SB)

    Time frame: Change between day 0, and 90, 180 days

    CDR-SB assesses the severity and progression of dementia

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Tolea, PhD

CONTACT

[email protected]

561-869-6810

Sponsors and collaborators

Lead sponsor

Herrick Medical LLC

Industry

Collaborators

  • University of Miami

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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