Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-03 @ 8:28 AM
Study NCT ID:
NCT06739668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization, 2:1, Active to Sham'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Successfully Completed Treatments', 'timeFrame': 'End of treatment, 4 weeks', 'description': 'Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.'}], 'secondaryOutcomes': [{'measure': 'Device comfort', 'timeFrame': 'End of treatment, 4 weeks', 'description': 'Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort.'}, {'measure': 'Device ease of use', 'timeFrame': 'End of treatment, 4 weeks', 'description': 'Ease of use will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater ease of use.'}, {'measure': 'Clarity of instructions', 'timeFrame': 'End of treatment, 4 weeks', 'description': 'Clarity of instructions will be assessed using a 5-point Likert scale, full scale from 1-5 with high scores indicating greater clarity of instructions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Post-Acute COVID-19 Syndrome', 'Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* English Speaking\n* SARS CoV-2 infection as documented by laboratory nucleic acid amplification test or antibody test ≥ 6 months from screening or signed attestation of positive test result\n* Experiencing PASC symptoms ≥ 6 months\n* Objective cognitive impairment on neuropsychological measures (as defined by a z-score ≥1 standard deviation below the normative mean) in executive functioning\n* Individuals of childbearing age agreeing to use a highly effective form of birth control\n\nExclusion Criteria:\n\n* History of cognitive dysfunction present prior to SARS CoV-2 infection\n* Febrile (\\> 99 F) at the time of the enrollment visit\n* Enrollment in another interventional clinical trial in the last 90 days or during the study period\n* Recent SARS CoV-2 reinfection in the last 30 days or during the study period\n* Recent SARS CoV-2 vaccination in the last 30 days or plans to be vaccinated during the 8 week study period\n* Currently taking immunomodulatory medication on an ongoing basis (NSAIDs, corticosteroids, cytokine antagonists, IVIG)\n* History of bipolar disorder, psychotic disorder, substance use disorder\n* Change in anti-depressant or other psychoactive medication or dose in the last 90 days\n* Cranially implanted devices or metal\n* Any serious unstable medical or neurologic condition\n* History of severe head injury (as defined by loss of consciousness for ≥30 minutes) or stroke in the past 12 months\n* Pregnant or plan to become pregnant during the study as indicated by positive pregnancy test\n* Serious immune/autoimmune diagnoses prior to SARS-CoV-2 infection\n* ME/CFS diagnosis prior to first SARS-CoV-2 infection\n* Existing diagnosis of Post-treatment Lyme Disease Syndrome\n* Inability to achieve appropriate positioning of the study device on the head'}, 'identificationModule': {'nctId': 'NCT06739668', 'briefTitle': 'Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY-24-01276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active device', 'description': 'The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.', 'interventionNames': ['Device: Pascal device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham device', 'description': 'The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.', 'interventionNames': ['Device: Sham Device']}], 'interventions': [{'name': 'Pascal device', 'type': 'DEVICE', 'description': 'The study devices consist of a tabletop Console with user interface and a head-worn applicator (Headset) that is connected via coaxial cable. The Headset is positioned on the head per instructions, and then the study subject powers on the device by pressing the power button and initiates a 15-minute treatment by pressing the start button. LED lights on the console count down during the treatment to indicate time remaining and, once the treatment is complete, the device automatically powers off.', 'armGroupLabels': ['Active device']}, {'name': 'Sham Device', 'type': 'DEVICE', 'description': 'The sham device will look identical to the active device and will have the same indicator lights and sounds, but will not emit magnetic field therapy.', 'armGroupLabels': ['Sham device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Putrino', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Humanity Neurotech Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Putrino', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}