Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-27 @ 1:52 PM
Study NCT ID:
NCT04640766
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lenard.Adler@nyulangone.org', 'phone': '212-263-3580', 'title': 'Lenard Adler, MD', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '11 Weeks', 'description': 'PI monitored for adverse events at every follow-up visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Insomnia + Vivid Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Soreness in Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '5.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. 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The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'spread': '7.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '9.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawn for inconsistency with visits and change in current medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '18 participants were enrolled; 9 of these participants failed screening. 9 participants started treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With ADHD', 'description': 'PRISM: The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline analysis population comprises individuals who began treatment in the study (n = 9).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-04', 'size': 890307, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-17T15:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2023-10-17', 'completionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2020-11-18', 'resultsFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2020-11-18', 'dispFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-17', 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)', 'timeFrame': 'Baseline', 'description': 'ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.'}, {'measure': 'Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)', 'timeFrame': 'Week 9', 'description': 'ADHD symptoms will also be measured using the Adult ADHD Investigator Symptom Rating Scale (AISRS). Items are scored as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). The maximum total score for the scale is 54 points, with 27 points for each subscale. The total score is the sum of the inattentive and hyperactive-impulsive subscales. The higher the score, the more severe the symptoms.'}, {'measure': 'Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)', 'timeFrame': 'Baseline', 'description': 'The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.'}, {'measure': 'Score on Attention-Deficit/Hyperactivity Disorder Self-Report Screening Scale for DSM-5-Expanded (DSM-5 ASRS Expanded)', 'timeFrame': 'Week 11', 'description': 'The DSM-5 ASRS Expanded consists of 18 questions. Each question is scored in the range 0-4, for a total range of score of 0-72. The higher the score, the more difficulty the participant is experiencing handling ADHD.'}, {'measure': 'Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report', 'timeFrame': 'Baseline', 'description': 'Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.'}, {'measure': 'Score on Behavioral Rating Inventory of Executive Function- Adult Version (BRIEF-A) Self-report', 'timeFrame': 'Week 11', 'description': 'Severity of executive function will be assessed via the Behavioral Rating Inventory of Executive Function- Adult version (BRIEF-A) self-report. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). The total range of score is 0-150; higher scores indicate poor executive function.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PRISM'], 'conditions': ['Attention Deficit Hyper Activity']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label feasibility study. Participants will be assigned and will undergo a novel neurofeedback intervention, targeting down-regulation of deep limbic structures, specifically the amygdalae. Participants will complete 12 neurofeedback sessions delivered twice weekly over 6 consecutive weeks. The intervention will be delivered via the PRISM platform.', 'detailedDescription': "The objectives include: 1)Training the NYU team on the electric finger print electroencephalography neurofeedback (EFP-EEG-NF) technology and provide them with hands-on experience; 2) Assessing participants' ability to learn the feedback paradigm (i.e. control the EFP-EEG-NF signal; time to achieve learning; assess learning curves); 3) Exploring preliminary results assessing target symptoms (e.g. AISRS and BRIEF-A)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ages 18-60 years, inclusive at the time of consent\n* Able to provide signed informed consent\n* Any gender\n* Subjects with a current primary DSM-5 diagnosis of ADHD (including predominantly inattentive presentation, hyperactive presentation, or combined presentations) as confirmed by the ACDS Version 1.2.\n* Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS score of ≥ 28 at screening. Subjects who are receiving pharmacological treatment for ADHD at screening must have a minimum AISRS score of ≥ 22 at screening\n* Not requiring treatment for any comorbid psychiatric condition for at least 2 months\n* Normal or corrected-to-normal vision\n* Normal or corrected-to-normal hearing\n* No intention of changing medication or psychotherapy for the duration of the study at the time of recruitment\n\nExclusion Criteria:\n\n* Concurrent substance abuse and/or history of substance use within 6 months\n* Use of any prescribed benzodiazepine\n* Lifetime bipolar disorder, psychotic disorder, autism, intellectual disability. Comorbid mood and anxiety disorders determined by the MINI will be permitted if they are not the primary focus of clinical attention\n* Active suicidality within past year, or history of suicide attempt in past 2 years\n* Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)\n* Any unstable medical or neurological condition\n* Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \\[TBI\\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)\n* Any psychotropic medication\n* Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \\[CPT\\], Prolonged Exposure \\[PE\\], Eye Movement Desensitization and Reprocessing \\[EMDR\\]); continuation of established maintenance supportive therapy will be permitted\n* Significant hearing loss or severe sensory impairment\n* Enrollment in another research study testing an experimental, clinical, or behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months'}, 'identificationModule': {'nctId': 'NCT04640766', 'briefTitle': 'Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Feasibility Open Label Study Evaluating the Use of Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults', 'orgStudyIdInfo': {'id': '20-01086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with ADHD', 'interventionNames': ['Device: PRISM']}], 'interventions': [{'name': 'PRISM', 'type': 'DEVICE', 'otherNames': ['EEG-based neurofeedback (EEG-NF) device'], 'description': 'The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.', 'armGroupLabels': ['Participants with ADHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Lenard Adler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.', 'accessCriteria': 'The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Lenard.Adler@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}