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A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04002167
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : May 5, 2021
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hadi Hosseini, Stanford University

Brief Summary:
The proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. We will test the proposed intervention on children with ADHD with working memory deficits. The R61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: Neurofeedback Behavioral: Cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Neurofeedback
The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.
Behavioral: Neurofeedback
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.

Primary Outcome Measures :
  1. 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.

  2. Change in working memory performance [ Time Frame: baseline, 3 and 6 weeks ]
    Accuracy in an N-back working memory task.

Secondary Outcome Measures :
  1. Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory t-score [ Time Frame: baseline and 6 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.

  2. Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index score [ Time Frame: baseline and 6 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

  3. Change in Conners 3rd Edition ADHD Index and Inattention t-score [ Time Frame: baseline and 6 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.

  4. 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.

Other Outcome Measures:
  1. Change in Continuous Performance Test (CPT) accuracy [ Time Frame: baseline and 6 weeks ]
    CPT is standard test for measuring vigilance, sustained attention and inhibitory control.

  2. Change in California Verbal Learning Test - Children's version (CVLT-C) score [ Time Frame: baseline and 6 weeks ]
    CVLT-C test measures performance in learning and recalling verbal materials

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria include:

  • Age from 7 to 11 years
  • Diagnosis and/or current symptoms of ADHD
  • Full-scale Intelligence quotient (IQ) ≥80
  • Behavior Rating Inventory of Executive Functions (BRIEF), Working Memory Scale t-score > 65
  • Allowed comorbidities include oppositional defiant disorder, learning disabilities excluding dyslexia, and mild anxiety and/or depression.

Exclusion criteria:

  • Presence of severe neurological or psychiatric disease other than those allowed under inclusion
  • Sensory deficits that would preclude participation in assessments or imaging
  • History of significant head trauma with loss of consciousness
  • Contraindications to MRI (e.g. metal implants or claustrophobia)
  • Enrollment in other intervention studies

Information from the National Library of Medicine

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 identifier (NCT number): NCT04002167

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Contact: Hannah Fingerhut 650-724-2939
Contact: Hadi Hosseini 6507235798

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Hannah Fingerhut    650-724-2939   
Principal Investigator: Hadi Hosseini, PhD         
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
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Principal Investigator: Hadi Hosseini Stanford University
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Responsible Party: Hadi Hosseini, Assistant Professor, Stanford University Identifier: NCT04002167    
Other Study ID Numbers: 328066
R61MH119289 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadi Hosseini, Stanford University:
Working memory
functional near infrared spectroscopy (fNIRS)
magnetic resonance imaging (MRI)
Cognitive training