Actively Recruiting
Pulsed Electromagnetic Field Treatment With Dementia Patients
Led by Herrick Medical LLC · Updated on 2025-05-18
48
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
H
Herrick Medical LLC
Lead Sponsor
U
University of Miami
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pulsed Electromagnetic Field Treatment With Dementia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosed with mild to moderate Alzheimer's disease or related dementias including Lewy body dementia and vascular dementia, with a global Clinical Dementia Rating of 0.5 or 1
- At least eighth grade level of education
- If female, post-menopausal
- Mini-Mental State Examination (MMSE) score between 16 and 26 inclusive
- Able to provide consent or have a surrogate able to consent if participant lacks capacity
- Willing and able to follow the study protocol
- If taking cholinesterase inhibitors or memantine, medication must be stable for at least 60 days prior to screening and continued throughout the study
- Physically cleared by a clinician for study participation
You will not qualify if you...
- Lack of capacity to consent without available surrogate
- No study partner available for interview
- History of epileptic seizures or epilepsy
- Diagnosis of Frontotemporal Dementia
- Taking medication that lowers seizure threshold (excluding blood thinners)
- Currently taking anti-amyloid monoclonal antibodies (past treatment allowed if stopped at least 3 months before baseline)
- Presence of depression, bipolar disorder, psychotic disorder, or other neurological or psychiatric conditions interfering with study
- Severe agitation interfering with study procedures
- Alcoholism or substance use disorder within past 5 years or severe sleep deprivation
- Major surgery requiring general anesthesia and hospitalization for more than 1 week within past 4 weeks
- Head anatomy preventing proper fit of the treatment device
- Participation in another clinical trial within past 30 days
- Metal implants in the head (except mouth implants) such as cochlear implants or brain stimulators
- Conditions increasing risks associated with blood draws
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Boca Raton, Florida, United States, 334233
Actively Recruiting
Research Team
M
Magdalena Tolea, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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