Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-01-03 @ 12:06 AM
Study NCT ID:
NCT03361293
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Training and tDCS for Children With FASD
Sponsor:
Organization:
Raw JSON
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'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwozniak@umn.edu', 'phone': '612-273-9741', 'title': 'Jeffrey Wozniak, PhD, LP', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '56 days', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scalp discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 19, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 31, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 38, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty paying attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unusual feelings, attitudes, emotions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in hearing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Twitching / muscle movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forgetfullness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Balance problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in dominant hand function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BrainHQ Learning Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '867.6', 'spread': '244.1', 'groupId': 'OG000'}, {'value': '861.7', 'spread': '264.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.', 'description': 'Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in D-KEFS Verbal Fluency - Letter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in D-KEFS Verbal Fluency - Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.68', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '-3.42', 'spread': '3.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in D-KEFS Trail-making - Numbers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in D-KEFS Trail-making - Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '3.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in D-KEFS Trail-making - Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.16', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '-2.05', 'spread': '6.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Delis Rating of Executive Functioning (D-REF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '73.2', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section', 'description': "The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment.", 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Flanker Inhibitory Control and Attention Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'OG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '3.52', 'spread': '8.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'FG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).\n\nActive tDCS: Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)\n\nCognitive training: BrainHQ Computerized cognitive training'}, {'id': 'BG001', 'title': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).\n\nCognitive training: BrainHQ Computerized cognitive training\n\nSham tDCS: Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Delis Rating of Executive Functioning (D-REF)', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '76.3', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study baseline (visit 1), pre-intervention. Greater values reflect greater executive functioning impairment.\n\nTime Frame: D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that outcome scores are listed in the appropriate section", 'unitOfMeasure': 't-score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-02', 'size': 654202, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-05T12:32', 'hasProtocol': True}, {'date': '2018-09-24', 'size': 486306, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-01-05T12:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and families will be blinded. The principal investigator will be blinded. The research staff member coordinating the visit will be blinded. The care provider is not involved in the research and is, therefore, blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomized allocation to active tDCS or placebo (sham tDCS).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-19', 'studyFirstSubmitDate': '2017-11-20', 'resultsFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2017-11-27', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-12', 'studyFirstPostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BrainHQ Learning Rate', 'timeFrame': 'Learning rate will be computed over 5 sessions of tDCS spanning 28 to 56 days; Each of the 5 tDCS sessions are 46 minutes long. The divided attention task is administered at the end of each tDCS session.', 'description': 'Participants completed a Divided Attention Task during 5 sessions of tDCS. Unit of measure: milliseconds Meaning: lowest threshold reached across trials / fastest reaction time Direction: lower values represent better performance'}], 'secondaryOutcomes': [{'measure': 'Change in D-KEFS Verbal Fluency - Letter', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.'}, {'measure': 'Change in D-KEFS Verbal Fluency - Category', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.'}, {'measure': 'Change in D-KEFS Trail-making - Numbers', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.'}, {'measure': 'Change in D-KEFS Trail-making - Letters', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.'}, {'measure': 'Change in D-KEFS Trail-making - Combined', 'timeFrame': 'D-KEFS will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Delis-Kaplan Executive Function System (D-KEFS) cognitive battery measures executive functioning skills. Task performance is in scaled score points based on items generated and errors (range of 1-19 with a mean of 10 and a standard deviation of 3). Here, we present difference scores between session 1 (baseline) and 5 (completion). Greater values represent more change. Positive values represent improvement; negative values represent decline in performance.'}, {'measure': 'Delis Rating of Executive Functioning (D-REF)', 'timeFrame': 'D-REF will be administered at baseline and at the final visit (28 to 56 days after baseline). NOTE that baseline scores are listed previously in the appropriate section', 'description': "The Delis Rating of Executive Functioning (D-REF) contains 60 items rated by the parent to measure the child's executive functioning compared to age-peers. Results are calculated as T-scores, which have a mean of 50 and a standard deviation of 10. Here, we present the scores at study completion (visit 5), post-intervention. Greater values reflect greater executive functioning impairment."}, {'measure': 'Change in Flanker Inhibitory Control and Attention Task', 'timeFrame': 'NIH Toolbox will be administered at baseline and at the final visit (28 to 56 days after baseline)', 'description': 'The Flanker Inhibitory Control and Attention Task from the NIH Toolbox measure inhibitory control and attention. Task performance is in T-scores based on correct items and errors (mean of 50 and a standard deviation of 10). Here, we present difference scores between session 1 (baseline) T-score and 5 (completion) T-score. Greater values represents more change. Positive values represent improvement; negative values represent decline in performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fetal Alcohol Spectrum Disorders']}, 'referencesModule': {'references': [{'pmid': '32360392', 'type': 'DERIVED', 'citation': 'Boroda E, Krueger AM, Bansal P, Schumacher MJ, Roy AV, Boys CJ, Lim KO, Wozniak JR. A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder. Brain Stimul. 2020 Jul-Aug;13(4):1059-1068. doi: 10.1016/j.brs.2020.04.015. Epub 2020 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 - 16 years) with prenatal alcohol exposure (PAE).', 'detailedDescription': 'Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated FASD diagnosis (FAS, partial FAS, or ARND).\n* An available parent or legal guardian capable of giving informed consent\n\nExclusion Criteria:\n\n* Substance abuse in the participant\n* Neurological condition or other developmental disorder\n* Serious psychiatric disorder known to affect brain functioning and cognitive performance\n* Birthweight \\< 1500 grams\n* MRI contraindication\n* tDCS contraindication'}, 'identificationModule': {'nctId': 'NCT03361293', 'briefTitle': 'Cognitive Training and tDCS for Children With FASD', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Neuromodulation Augmented Cognitive Remediation to Improve Executive Dysfunction in Fetal Alcohol Spectrum Disorder (FASD)', 'orgStudyIdInfo': {'id': 'PSYCH-2017-26075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Training and Active tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus active tDCS (also 5 sessions).', 'interventionNames': ['Device: Active tDCS', 'Behavioral: Cognitive training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Cognitive Training and Sham tDCS', 'description': '5 sessions of computerized cognitive training on tasks of attention, concentration, set-shifting, and memory - plus sham tDCS (also 5 sessions) which consists of "placebo" stimulation with tDCS (ramp-up, but no actual stimulation).', 'interventionNames': ['Behavioral: Cognitive training', 'Device: Sham tDCS']}], 'interventions': [{'name': 'Active tDCS', 'type': 'DEVICE', 'description': 'Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)', 'armGroupLabels': ['Cognitive Training and Active tDCS']}, {'name': 'Cognitive training', 'type': 'BEHAVIORAL', 'description': 'BrainHQ Computerized cognitive training', 'armGroupLabels': ['Cognitive Training and Active tDCS', 'Cognitive Training and Sham tDCS']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)', 'armGroupLabels': ['Cognitive Training and Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Jeffrey Wozniak, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}