A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT04002167|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Behavioral: Neurofeedback Behavioral: Cognitive training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory|
|Estimated Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.
The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
Active Comparator: Cognitive Training
The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.
Behavioral: Cognitive training
The Cognitive training group will receive computerized working memory training with performance feedback.
No Intervention: Waitlist
Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
- Change in target frontal-parietal activity [ Time Frame: baseline, 3 and 6 weeks ]Increased activity in the target frontal-parietal network measured by functional MRI (fMRI) and functional near infrared spectroscopy (fNIRS) during an N-back working memory task.
- Change in working memory performance [ Time Frame: baseline, 3, 6, and 12 weeks ]Accuracy in an N-back working memory task.
- Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory t-score [ Time Frame: baseline, 6, and 12 weeks ]BRIEF assesses everyday behavior associated with specific domains of the executive functions. BRIEF working memory t-score ranges from <30 to >100 with higher scores indicating larger impairment in working memory.
- Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), Working Memory Index score [ Time Frame: baseline, 6, and 12 weeks ]WRAML-2 assesses clinical issues in learning and memory functions. WRAML-2 Working Memory Index score ranges from 50 to 150 with higher scores indicating better working memory performance
- Change in Conners 3rd Edition ADHD Index and Inattention t-score [ Time Frame: baseline, 6, and 12 weeks ]Conners 3 will be used to measure changes in clinical ADHD symptoms. Conners 3 ADHD index score ranges from 0 to 100 with higher scores indicating more ADHD symptoms. Inattention t-score ranges from <30 to >100 with higher scores indicating more inattention problems.
- Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) composite score [ Time Frame: baseline and 6 weeks ]NEPSY-II consists of a set of subtests measuring cognitive functions required for success in school. The subtests include auditory attention & response, inhibition, word-list interference, and comprehension of instructions. The scaled scores on all subtests range from 0 to 20. The composite score will be quantified using principal component analysis on accuracy across these subtests.
- Change in NIH Toolbox Cognition composite score [ Time Frame: baseline, 6, and 12 weeks ]NIH Toolbox Cognition is a set of computerized assessments for measuring executive functions and memory. The composite score will be quantified using principal component analysis on standard scores of list-sort working memory test, flanker inhibitory control and attention test, and picture sequence memory test. Standard scores range from 50 to 150.
- Change in Continuous Performance Test (CPT) accuracy [ Time Frame: baseline, 6, and 12 weeks ]CPT is standard test for measuring vigilance, sustained attention and inhibitory control.
- Change in Rapid Automatized Naming Test (RAN) accuracy [ Time Frame: baseline, 6, and 12 weeks ]RAN is a standard test for measuring reading fluency
- Change in California Verbal Learning Test - Children's version (CVLT-C) score [ Time Frame: baseline, 6, and 12 weeks ]CVLT-C test measures performance in learning and recalling verbal materials
- Change in Parent Stress Index 4th Edition (PSI-IV) [ Time Frame: baseline and 6 weeks ]PSI-IV evaluates the magnitude of stress in the parent-child system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002167
|Contact: Hannah Fingerhutfirstname.lastname@example.org|
|Contact: Hadi Hosseiniemail@example.com|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Hannah Fingerhut 650-724-2939 firstname.lastname@example.org|
|Principal Investigator: Hadi Hosseini, PhD|
|Principal Investigator:||Hadi Hosseini||Stanford University|