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OpenTrials
Completed

NCT Number: NCT04002167

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback

Behavioral

The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.

Cognitive training

Behavioral

The Cognitive training group will receive computerized working memory training with performance feedback.

Primary outcomes

  1. Change in Target Frontal-parietal Activity

    Time frame: baseline and 6 weeks

    Change in activity in the target frontal-parietal network measured by functional near infrared spectroscopy (fNIRS) during an N-back working memory task. A general linear model is applied to recorded signal and the beta coefficients from the model are extracted as a proxy for brain activity in fronto-pariteal network which subserves working memory function. There is no established population mean for beta coefficient of brain activity. Higher (lower) beta coefficients reflect higher (lower) activation in the target brain network. A positive change indicates increased brain activity. Increased frontal-parietal activity reflects better engagement of this brain network during working memory performance.

  2. Change in Working Memory Performance

    Time frame: baseline and 6 weeks

    Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.

Secondary outcomes

  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. Lower T-scores on BRIEF indicates better working memory. T-score of 50 indicates the population mean with a standard deviation of 10. BRIEF working memory T-score of 65 and higher is indicative of deficits 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 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 elevated ADHD symptoms. Conners 3 ADHD index score of higher than 65 is indicative of ADHD diagnosis.

  4. Change in Conners 3rd Edition Inattention T-score

    Time frame: baseline and 6 weeks

    Conners 3 will be used to measure changes in clinical inattention symptoms. Conners 3 inattention t-score ranges from <30 to >100 with higher scores indicating larger impairment in attention. T-score of 50 indicates the population mean with a standard deviation of 10. Inattention t-score of 65 and higher is indicative of deficits in attention.

  5. 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 composite scores were quantified by averaging the scores across sub-scales. A positive change in composite score suggests increased ability in subtest domains. The composite score below 8 suggest deficits. The composite scores range from 0 to 20; lower scores correspond to more deficits, and higher scores correspond to more abilities.

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2019
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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