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

Stanford University65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

ADHD

Interventions

NeurofeedbackBEHAVIORAL

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

Cognitive trainingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Change in Target Frontal-parietal Activity

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.

Time frame: baseline and 6 weeks

Change in Working Memory Performance

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

Time frame: baseline and 6 weeks

Secondary Outcomes

Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score

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.

Time frame: baseline and 6 weeks

Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score

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

Time frame: baseline and 6 weeks

Data from ClinicalTrials.gov

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