Pulsed Electromagnetic Field Treatment In Patients With Alzheimer's Disease

NCT05295615 | Recruiting FDA Device

• 1 other identifier: HM003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alzheimer Disease

Outcome Measures

Primary Outcomes (4)

• The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.

  Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

• Mini-Mental Status Exam (MMSE)

  Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity

  Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

• Global Deterioration questionnaire

  Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity

  Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

• Quality of Life Scale

  Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity

  Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days

Study Arms (1)

Active ECHS AD device

EXPERIMENTAL

Experimental intervention arm

Device: ECHS AD Device

Interventions

ECHS AD Device DEVICE

Pulsed electromagnetic therapy device

Active ECHS AD device

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herrick Medical LLC: lead
• Hackensack Meridian Health: collaborator

Study Sites (1)

Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Manisha Parulekar, MD

CONTACT

551-996-1140; manisha.parulekar@hmhn.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active treatment

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 25, 2022
• Study Start: May 1, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

US (1)