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

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Behavioral: Cognitive training; Behavioral: Neurofeedback

• Registration Number: NCT04002167
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Study Start: 2019-08-16
• Primary Completion: 2022-08-26
• Study Completion: 2022-09-14
• Results First Submitted: 2023-08-25
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Results First Posted: 2023-12-13
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Training	Cognitive training	The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.
Neurofeedback	Neurofeedback	The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.

Primary Outcome Measures

Name	Time	Method
Change in Working Memory Performance	baseline and 6 weeks	Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.
Change in Target Frontal-parietal Activity	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.

Secondary Outcome Measures

Name	Time	Method
Change in Conners 3rd Edition Inattention T-score	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.
Change in Conners 3rd Edition ADHD Index Score	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.
Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score	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.
Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score	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
Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States