Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-30 @ 12:19 PM
Study NCT ID:
NCT04729257
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Norms Expansion and Validation for IntelliSpace Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-03-21', 'mcpReleaseN': 3, 'releaseDate': '2023-02-23'}, {'resetDate': '2023-04-21', 'mcpReleaseN': 4, 'releaseDate': '2023-03-31'}, {'resetDate': '2023-05-19', 'mcpReleaseN': 5, 'releaseDate': '2023-04-25'}, {'resetDate': '2023-06-21', 'mcpReleaseN': 6, 'releaseDate': '2023-05-26'}], 'estimatedResultsFirstSubmitDate': '2023-02-23'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform.', 'timeFrame': '1.5 hours'}, {'measure': 'or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests', 'timeFrame': '0.75 h or 1.5 hours'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cognitive model', 'Cognitive assessment', 'Digital cognitive tests', 'Automated scoring', 'Algorithms'], 'conditions': ['Cognitive Functioning of Healthy Individuals']}, 'descriptionModule': {'briefSummary': 'This study aims to expand the normative dataset for Philips IntelliSpace Cognition to include ages 18-49 and 80+ and aims to validate two new digital tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is 18 years or older.\n* Participant's primary language (language most often spoken) must be American English.\n* Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).\n* Participant is able to hear well (naturally of corrected by means of a hearing aid).\n* Participant is able to use their fingers, hands and arms to write symbols.\n* Participant has valid health insurance in USA.\n* Participant is able to give informed consent.\n* Participant is able to understand test instructions and participate fully in testing.\n* Participant has normal fine and gross motor ability.\n\nExclusion Criteria:\n\nInclusion Criteria:\n\n* Participant is 18 years or older.\n* Participant's primary language (language most often spoken) must be American English.\n* Participant is able to see well (naturally or corrected by means of eyeglasses or lenses).\n* Participant is able to hear well (naturally of corrected by means of a hearing aid).\n* Participant is able to use their fingers, hands and arms to write symbols.\n* Participant has valid health insurance in USA.\n* Participant is able to give informed consent.\n* Participant is able to understand test instructions and participate fully in testing.\n* Participant has normal fine and gross motor ability.\n\nExclusion Criteria:\n\n* Participant is currently admitted to a hospital, assisted living, nursing home or a psychiatric facility.\n* Participant is diagnosed with a neurological disorder or disease that may affect cognitive functioning (e.g., Parkinson's, brain tumor, stroke, Traumatic Brain Injury (TBI), epilepsy \\[if # seizures ≤ 2 and not receiving ongoing treatment for seizures, and not currently seeking medical evaluation or attention related to seizures, participant can be accepted\\], encephalitis, dementia).\n* Participant is diagnosed with a language disorder or aphasia (expressive or mixed receptive/expressive) \\[if articulation disorder, participant can be accepted\\].\n* Participant is diagnosed with a learning disorder.\n* Participant is diagnosed with an autoimmune disorder that may affect cognitive functioning (e.g., LUPUS, Multiple Sclerosis).\n* Participant is or was diagnosed with a current or past psychotic disorder (e.g., schizophrenia).\n* Participant is diagnosed with a severe mood disorder \\[if Major Depressive Disorder in remission or with no current episode or Dysthymic Disorder or Adjustment Disorder, participant can be accepted\\].\n* Participant is diagnosed with a severe anxiety disorder \\[if Phobia or Anxiety disorders with symptoms not significant enough to interfere with test performance, participant can be accepted\\].\n* Participant is or was diagnosed with current or past Autism Spectrum Disorder or Intellectual Disability.\n* Participant is diagnosed with a current substance abuse or dependence \\[if in remission ≥ 1 year, participant can be accepted\\].\n* Participant has carried a substance abuse or dependence diagnosis for more than 10 years at any point in their life.\n* Participant has an average alcohol consumption of 4 or more units per day.\n* Participant uses medical marijuana.\n* Participant uses recreational marijuana more than once a week.\n* Participant uses recreational drugs other than alcohol and marijuana in the last 6 months (e.g., cocaine, ecstasy, LSD).\n* Participant has been unconscious related to traumatic brain injury or 'medical condition' for more than 20 minutes \\[if medication-induced or due to heat stroke, participant can be accepted\\].\n* Participant has stayed in a hospital overnight due to a head injury.\n* Participant has had a medical event requiring resuscitation in which they were non-responsive for more than 15 minutes.\n* Participant has received chemotherapy treatment in the past 2 months.\n* Participant has received electroconvulsive therapy (ECT).\n* Participant has received radiation to the central nervous system.\n* Participant experiences a physical condition or illness that interferes with normal cognitive functioning at work, school, Instrumental Activities of Daily Living (IADLs) etc. \\[if diabetes or hypothyroidism or hypertension and if controlled, participant can be accepted\\].\n* Participant is currently taking anti-convulsants (Depakote, Lamictal or Lyrica, Gabapentin, Keppra, Topamax, Divalproex Sodium, Valproate Sodium, Levetiracetam, Lamotrigine, Pregabalin, Topiramate).\n* Participant is currently taking anti-psychotics (Abilify, Rexulti, Zyprexa, Clozaril, Clozapine, Latuda, Seroquel, Risperdal, Risperidone, Aripipazle, Bexipiprazole, Olanzapine, Lurasidone HCL, Quetiapine).\n* Participant is currently taking benzodiazepines (Diazepams, Valium, Klonopin, Ativan, Xanax, Lorazepam, Alprazolam, Clonazepam).\n* Participant is currently taking psychostimulants (Amphetamines, Adderall, Ritalin, Methamphetamines, Dextroamphetamine, Methylphenidate HCL). \\[if coffee, participant can be accepted\\].\n* Participant is currently taking opioids (Oxycontin, Tramadol, Codeine, Dilaudid, Suboxone, Oxycodone, Percocet, Buprenorhine, Naloxone).\n* Participant is currently taking antidepressants (Amitriptyline, Elavil, Pamelor, Tofranil, Vivactil, Imipramine, Protriptyline HCL). \\[if antidepressant that are not tricyclic, participant can be accepted\\].\n* Participant is currently taking oxybutynin (Ditropan).\n* Participant is currently seeking medical diagnostic procedures for cognitive difficulties from a medical professional.\n* Participant has received neuropsychological testing before. \\[if previous MMSE(-2) or MoCA testing more than 6 months prior, participant can be accepted\\].\n* Participant shows evidence of current cognitive impairment.\n* Participant displays disruptive behavior or insufficient compliance with testing to ensure a valid assessment.\n* Participant is primarily nonverbal or uncommunicative."}, 'identificationModule': {'nctId': 'NCT04729257', 'briefTitle': 'Norms Expansion and Validation for IntelliSpace Cognition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Electronics Nederland B.V. acting through Philips CTO organization'}, 'officialTitle': 'Norms Expansion and Validation for IntelliSpace Cognition', 'orgStudyIdInfo': {'id': 'ICBE-S-000233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)', 'description': "Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests.", 'interventionNames': ['Device: Philips IntelliSpace Cognition (ISC).', 'Diagnostic Test: Paper-Pencil Tests.']}, {'type': 'OTHER', 'label': 'Group B (Validation, 18+)', 'description': "Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests.", 'interventionNames': ['Device: Philips IntelliSpace Cognition (ISC).', 'Diagnostic Test: Paper-Pencil Tests.']}, {'type': 'OTHER', 'label': 'Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years)', 'description': "Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using digital tests.", 'interventionNames': ['Device: Philips IntelliSpace Cognition (ISC).']}, {'type': 'OTHER', 'label': 'Group D (Validation, 18+)', 'description': "Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using paper-pencil tests.", 'interventionNames': ['Diagnostic Test: Paper-Pencil Tests.']}, {'type': 'OTHER', 'label': 'Group E (Norms, 18-49 years)', 'description': "Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A", 'interventionNames': ['Device: Philips IntelliSpace Cognition (ISC).']}, {'type': 'OTHER', 'label': 'Group F (Norms, 80-95 years)', 'description': "Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A", 'interventionNames': ['Device: Philips IntelliSpace Cognition (ISC).']}], 'interventions': [{'name': 'Philips IntelliSpace Cognition (ISC).', 'type': 'DEVICE', 'description': 'Philips ISC is a Class-II Medical Device in the US that aids in assessing cognition and helps inform the HealthCare Professional (HCP) to make a diagnosis and treatment plan. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.', 'armGroupLabels': ['Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)', 'Group B (Validation, 18+)', 'Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years)', 'Group E (Norms, 18-49 years)', 'Group F (Norms, 80-95 years)']}, {'name': 'Paper-Pencil Tests.', 'type': 'DIAGNOSTIC_TEST', 'description': 'The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.', 'armGroupLabels': ['Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years)', 'Group B (Validation, 18+)', 'Group D (Validation, 18+)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19073', 'city': 'Newtown Square', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research America Inc.', 'geoPoint': {'lat': 39.98678, 'lon': -75.40103}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Electronics Nederland B.V. acting through Philips CTO organization', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Research America Inc.', 'class': 'INDUSTRY'}, {'name': 'Qserve', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}