Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-01-02 @ 10:49 AM
Study NCT ID:
NCT06862557
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsed Electromagnetic Field Treatment With Dementia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Active treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-03-02', 'studyFirstSubmitQcDate': '2025-03-02', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)", 'timeFrame': 'Change between day 0, and 45, 90, 135, 180 days', 'description': 'Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental Status Exam (MMSE)', 'timeFrame': 'Change between day 0, and 45, 90, 135, 180 days', 'description': 'Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity'}, {'measure': 'Quality of Life Scale', 'timeFrame': 'Change between day 0, and 45, 90, 135, 180 days', 'description': 'Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity'}, {'measure': 'Global Deterioration questionnaire', 'timeFrame': 'Change between day 0, and 45, 90, 135, 180 days', 'description': 'Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity'}, {'measure': 'Side-Effects Questionnaire', 'timeFrame': 'Change between day 0, and 45, 90, 135, 180 days', 'description': 'Self-report of side-effects'}, {'measure': 'Clinical Dementia Rating (CDR) sum of boxes (CDR-SB)', 'timeFrame': 'Change between day 0, and 90, 180 days', 'description': 'CDR-SB assesses the severity and progression of dementia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'Lewy Body Dementia', 'Vascular Dementia']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD/ADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.\n\n3\\. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 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) 10. Physical clearance for study participation as evaluated by the clinician\n\nExclusion Criteria:\n\n1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent\n2. The patient does not have a study partner who would be available for interview\n3. History of epileptic seizures or epilepsy\n4. Has Frontotemporal Dementia\n5. Currently taking medication that lowers the seizure threshold, excluding blood thinners\n6. Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit).\n7. 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\n8. Severe agitation that would interfere with study procedures\n9. 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\n10. 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\n11. Head anatomy that interferes with the fit of the treatment device\n12. Participation in another clinical trial within the previous 30 days\n13. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth\n14. Criteria to exclude participants from the blood draw study:\n\nAny condition that may significantly increase risks associated with blood draws"}, 'identificationModule': {'nctId': 'NCT06862557', 'briefTitle': 'Pulsed Electromagnetic Field Treatment With Dementia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Herrick Medical LLC'}, 'officialTitle': 'Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'HM004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active ECHS AD device', 'description': 'Experimental intervention arm', 'interventionNames': ['Device: ECHS AD Device']}], 'interventions': [{'name': 'ECHS AD Device', 'type': 'DEVICE', 'description': 'Pulsed electromagnetic therapy device', 'armGroupLabels': ['Active ECHS AD device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '334233', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Magdalena Tolea, PhD', 'role': 'CONTACT', 'email': 'mit38@med.miami.edu', 'phone': '561-869-6810'}, {'name': 'Magdelena Tolea, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James Galvin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcia Walker, APRN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicole Mendez, APRN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'centralContacts': [{'name': 'Magdalena Tolea, PhD', 'role': 'CONTACT', 'email': 'mit38@med.miami.edu', 'phone': '561-869-6810'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herrick Medical LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Miami', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}