Pulsed Electromagnetic Field Treatment With Dementia Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorHerrick Medical LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
The patient does not have a study partner who would be available for interview
History of epileptic seizures or epilepsy
Has Frontotemporal Dementia
Trial design
Design model
Single group
Treatments tested in this trial
ECHS AD Device
DevicePulsed electromagnetic therapy device
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Active ECHS AD deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change between day 0, and 45, 90, 135, 180 daysSecondary outcomes
1
Mini-Mental Status Exam (MMSE)
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
Time frame
Change between day 0, and 45, 90, 135, 180 days2
Quality of Life Scale
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Time frame
Change between day 0, and 45, 90, 135, 180 days3
Global Deterioration questionnaire
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Time frame
Change between day 0, and 45, 90, 135, 180 days4
Side-Effects Questionnaire
Self-report of side-effects
Time frame
Change between day 0, and 45, 90, 135, 180 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Herrick Medical LLC
Lead sponsor
University of Miami
Collaborator
Source ClinicalTrials.gov