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RecruitingNCT05295615Updated Sep 17, 2026

Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease

An interventional study of ECHS AD Device in Alzheimer Disease, 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
40
Allocation
Not applicable
Ages
50 Years to 100 Years
Sex
All
01

Study summary

An open label pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD 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 points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.

02

Conditions studied

  • Alzheimer Disease

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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. Patients diagnosed with mild to moderate Alzheimer's Dementia defi
  3. At least an eighth grade of educational achievement
  4. If female, post-menopausal.
  5. MMSE score between 16 and 26
  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)
  9. Spouse, family member or professional caregiver agree and are capable of taking care of the participation of the patient in the study (answering questions regarding the patient's condition, assuming responsibility for medication, and applying and supervising the daily PEMF treatments)
  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. History of epileptic seizures or epilepsy
  3. Currently taking medication that lowers the seizure threshold
  4. 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
  5. Severe agitation that would interfere with study procedures
  6. 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
  7. 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
  8. Head anatomy that interferes with the fit of the treatment device
  9. Participation in another clinical trial within the previous 30 days
  10. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 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 30, 60, 90, 120, 150, 240, 310, 400 days

  2. Mini-Mental Status Exam (MMSE)

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

    Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

  3. Global Deterioration questionnaire

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

    Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

  4. Quality of Life Scale

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

    Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

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Study locations

1 of 1 sites recruiting
  • Hackensack Medical Center
    Hackensack, New Jersey 07601, United States
    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
NCT05295615
Lead sponsor
Herrick Medical LLC
Collaborators
Hackensack Meridian Health
Responsible party
Sponsor
First posted
Mar 25, 2022
Start date
May 1, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Manisha Parulekar, MD
Contact
manisha.parulekar@hmhn.org
551-996-1140

Oversight

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

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