CClinicalTrials.gg
RecruitingNCT06862557Updated Sep 17, 2026

Pulsed Electromagnetic Field Treatment With Dementia Patients

An interventional study of ECHS AD Device in Alzheimer's Disease, Lewy Body Dementia and Vascular Dementia, sponsored by Herrick Medical LLC. Recruiting at 1 site in United States. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Herrick Medical LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
50 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Alzheimer's Disease
  • Lewy Body Dementia
  • Vascular Dementia
03

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
  2. The patient does not have a study partner who would be available for interview
  3. History of epileptic seizures or epilepsy
  4. Has Frontotemporal Dementia
  5. Currently taking medication that lowers the seizure threshold, excluding blood thinners
  6. 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).
  7. 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
  8. Severe agitation that would interfere with study procedures
  9. 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
  10. 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
  11. Head anatomy that interferes with the fit of the treatment device
  12. Participation in another clinical trial within the previous 30 days
  13. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
  14. Criteria to exclude participants from the blood draw study:

Any condition that may significantly increase risks associated with blood draws

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Active ECHS AD device

    Experimental intervention arm

    Device: ECHS AD Device

Interventions

  • DeviceECHS AD Device

    Pulsed electromagnetic therapy device

05

What researchers measure

Primary outcomes

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

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

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

Secondary outcomes

  1. Mini-Mental Status Exam (MMSE)

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

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

  2. Quality of Life Scale

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

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

  3. Global Deterioration questionnaire

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

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

  4. Side-Effects Questionnaire

    Self-report of side-effects

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

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

    CDR-SB assesses the severity and progression of dementia

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

06

Study locations

1 of 1 sites recruiting
  • University of Miami
    Boca Raton, Florida 334233, United States
    • Magdalena Tolea, PhD · Contact · mit38@med.miami.edu · 561-869-6810
    • Magdelena Tolea, PhD · Principal investigator
    • James Galvin, MD · Sub investigator
    • Marcia Walker, APRN · Sub investigator
    • Nicole Mendez, APRN · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06862557
Lead sponsor
Herrick Medical LLC
Collaborators
University of Miami
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Apr 1, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Magdalena Tolea, PhD
Contact
mit38@med.miami.edu
561-869-6810

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion