Actively Recruiting
Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
Led by Herrick Medical LLC · Updated on 2024-11-01
40
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
H
Herrick Medical LLC
Lead Sponsor
H
Hackensack Meridian Health
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosed with mild to moderate Alzheimer's Dementia
- At least eighth grade education
- If female, must be post-menopausal
- Mini-Mental State Exam score between 16 and 26
- Able to provide consent or have a surrogate able to consent
- Willing and able to follow study protocol
- If taking cholinesterase inhibitors or memantine, medication must be stable for at least 60 days prior to screening and maintained during study
- Caregiver (spouse, family member, or professional) available and capable to assist with study participation
- Physical clearance for participation as determined by clinician
You will not qualify if you...
- Lack of capacity to consent and no surrogate available
- History of epileptic seizures or epilepsy
- Taking medications lowering seizure threshold
- Presence of depression, bipolar disorder, psychotic disorder, or other interfering neurological or psychiatric conditions
- Severe agitation that would interfere with study
- Alcoholism or substance use disorder within last 5 years or severe sleep deprivation
- Major surgery requiring >1 week hospitalization within 4 weeks prior
- Head anatomy preventing proper device fit
- Participation in another clinical trial within past 30 days
- Metal implants in the head, except metal implants in the mouth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
M
Manisha Parulekar, MD
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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