NCT05295615 · Herrick Medical LLC
Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
ECHS AD Device
Pulsed electromagnetic therapy device
Primary outcome measures
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
Mini-Mental Status Exam (MMSE)
Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
Global Deterioration questionnaire
Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Quality of Life Scale
Time frame: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 50 years
- Patients diagnosed with mild to moderate Alzheimer's Dementia defi
- At least an eighth grade of educational achievement
- If female, post-menopausal.
- MMSE score between 16 and 26
- Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity
- Able and willing to comply with the protocol
- 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)
- 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)
- Physical clearance for study participation as evaluated by the clinician
Exclusion criteria
- The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
- History of epileptic seizures or epilepsy
- Currently taking medication that lowers the seizure threshold
- 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
- Severe agitation that would interfere with study procedures
- 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
- 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
- Head anatomy that interferes with the fit of the treatment device
- Participation in another clinical trial within the previous 30 days
- Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
Where
- Hackensack, New Jersey
Collaborators
Hackensack Meridian Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 1, 2024 · Source of record for eligibility and locations