Pulsed Electromagnetic Field Treatment With Dementia Patients
Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 120 days, 9 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "They will treat themselves at home three times a day for 15 minutes over 120 days."
- "Participants will be followed-up for 9 months post-treatment."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a device that sends pulses of electromagnetic energy affects how dementia gets worse. It is for adults age 50 or older with mild to moderate Alzheimer's disease or related dementia. Participants use the device at home for 15 minutes, three times a day, for 120 days, with follow-up for 9 months after treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 50 or older.
- Have mild to moderate Alzheimer's disease, Lewy body dementia, or vascular dementia, with a Clinical Dementia Rating (CDR) score of 0.5 or 1.
- Have finished at least eighth grade.
- If female, have gone through menopause.
- Score 16 to 26 on the MMSE, a test of memory and thinking.
- Can agree to join, or have someone who can agree for you. Must be able and willing to follow study steps.
- If taking a cholinesterase inhibitor or memantine for dementia, have taken it for at least 3 months before screening. The dose must be unchanged for at least 60 days before screening and stay the same during the study.
- A clinician finds you physically able to take part.
Who can't join
- Cannot agree to join and have no one to agree for you, or have no study partner available for an interview.
- Have a history of seizures or epilepsy, have frontotemporal dementia, or take medicine that makes seizures more likely. Blood thinners are not excluded by this medicine rule.
- Take anti-amyloid antibody medicines, which target amyloid protein. Past use is allowed if treatment ended at least 3 months before the first study visit.
- Have a current or past mental health or nervous system condition that the study doctor thinks would interfere, severe agitation that interferes with study steps, or a severe lack of sleep.
- Have had an alcohol or drug use disorder within the past 5 years, under the study's stated rules: addiction lasting more than 1 year and/or recovery lasting less than 3 years.
- Had major belly, blood vessel, or chest surgery within 4 weeks that required being fully asleep and a hospital stay longer than 1 week, or joined another clinical trial within 30 days.
- Your head shape prevents the device from fitting, or you have metal implants in your head. Metal implants in the mouth are allowed.
- For the blood draw part only: have a condition that could greatly increase the risks of drawing blood.
Simplified for readability. The official criteria below are what the study team uses.
Official 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: 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
Study sites (1)
FL
- University of Miami · Boca Raton, FL 334233Magdalena Tolea, PhD · Study contact · 561-869-6810 · mit38@med.miami.eduMagdelena Tolea, PhD · Principal investigatorJames Galvin, MD · Sub-investigatorMarcia Walker, APRN · Sub-investigatorMore trials in Boca Raton