Clinical trial NCT04002167: A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Working memory
functional near infrared spectroscopy (fNIRS)
magnetic resonance imaging (MRI)
Neurofeedback
Cognitive training
Neuromonitoring
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-06-28
Enrollment: 65
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Target Frontal-parietal Activity
timeFrame: baseline and 6 weeks
measure: Change in Working Memory Performance
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score
timeFrame: baseline and 6 weeks
measure: Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score
timeFrame: baseline and 6 weeks
measure: Change in Conners 3rd Edition ADHD Index Score
timeFrame: baseline and 6 weeks
measure: Change in Conners 3rd Edition Inattention T-score
timeFrame: baseline and 6 weeks
measure: Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score
timeFrame: baseline and 6 weeks
Other outcomes:
measure: Change in Continuous Performance Test (CPT) Accuracy
timeFrame: baseline and 6 weeks
measure: Change in California Verbal Learning Test - Children's Version (CVLT-C) Score
timeFrame: baseline and 6 weeks
measure: Change in Parent Stress Index 4th Edition (PSI-IV)
timeFrame: baseline and 6 weeks
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Hadi Hosseini
role: PRINCIPAL_INVESTIGATOR
References: