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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002167
• Other study ID #: 328066
• Secondary ID: R61MH119289
• Status: Completed
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: September 14, 2022

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 14, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Neurofeedback
The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
• Cognitive training
The Cognitive training group will receive computerized working memory training with performance feedback.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Continuous Performance Test (CPT) Accuracy	CPT is standard test for measuring vigilance, sustained attention and inhibitory control.	baseline and 6 weeks
Other	Change in California Verbal Learning Test - Children's Version (CVLT-C) Score	CVLT-C test measures performance in learning and recalling verbal materials	baseline and 6 weeks
Other	Change in Parent Stress Index 4th Edition (PSI-IV)	PSI-IV evaluates the magnitude of stress in the parent-child system	baseline and 6 weeks
Primary	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.	baseline and 6 weeks
Primary	Change in Working Memory Performance	Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.	baseline and 6 weeks
Secondary	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.	baseline and 6 weeks
Secondary	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	baseline and 6 weeks
Secondary	Change in Conners 3rd Edition ADHD Index Score	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.	baseline and 6 weeks
Secondary	Change in Conners 3rd Edition Inattention T-score	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.	baseline and 6 weeks
Secondary	Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score	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.	baseline and 6 weeks