Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease 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 the ECHS AD device, which sends pulses of electromagnetic energy, affects how Alzheimer's disease progresses. It is for adults age 50 or older with mild to moderate Alzheimer's disease. Everyone gets an active device to use 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 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.
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, with mild to moderate Alzheimer's disease.
- Completed at least eighth grade.
- Women must have gone through menopause.
- Score of 16 to 26 on the MMSE, a test of memory and thinking.
- Can agree to join, or have someone who can give permission for you.
- Able and willing to follow study rules, and cleared by a clinician to take part.
- If taking Alzheimer's drugs called cholinesterase inhibitors or memantine, have taken them 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.
- Have a spouse, family member, or paid caregiver who can answer questions about your health, manage medicines, and give and oversee daily treatments.
Who can't join
- Cannot give permission to join and have no one who can give permission for you.
- Have a history of seizures or epilepsy, or take medicine that makes seizures more likely.
- Have a current or past mental health or nervous system condition that the study doctor thinks would interfere with the study, or severe agitation that would interfere.
- Have an alcohol or drug use disorder within the last 5 years, with addiction lasting more than 1 year and/or recovery lasting less than 3 years; or have a severe lack of sleep.
- Had major belly, blood vessel, or chest surgery within 4 weeks that required medicine to put you fully asleep and a hospital stay longer than 1 week.
- Have a head shape that keeps the device from fitting.
- Took part in another clinical trial in the last 30 days.
- Have metal implants in the head, such as hearing implants, brain stimulators, or clips used to treat bulging blood vessels. Metal implants in the mouth are allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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: 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
Study sites (1)
NJ
- Hackensack Medical Center · Hackensack, NJ 07601More trials in Hackensack