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

NCT04002167 | Completed Results DMC

• 2 other identifiers: 328066R61MH119289
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; Working memory; functional near infrared spectroscopy (fNIRS); magnetic resonance imaging (MRI); Neurofeedback; Cognitive training; Neuromonitoring

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

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

  baseline and 6 weeks

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

  baseline and 6 weeks

• Change in Conners 3rd Edition ADHD Index Score

  baseline and 6 weeks

• Change in Conners 3rd Edition Inattention T-score

  baseline and 6 weeks

• Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score

  baseline and 6 weeks

Other Outcomes (3)

• Change in Continuous Performance Test (CPT) Accuracy

  baseline and 6 weeks

• Change in California Verbal Learning Test - Children's Version (CVLT-C) Score

  baseline and 6 weeks

• Change in Parent Stress Index 4th Edition (PSI-IV)

  baseline and 6 weeks

Study Arms (3)

Neurofeedback

EXPERIMENTAL

The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.

Behavioral: Neurofeedback

Cognitive Training

ACTIVE COMPARATOR

The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.

Behavioral: Cognitive training

Waitlist

NO INTERVENTION

Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.

Interventions

Neurofeedback BEHAVIORAL

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

Neurofeedback

Cognitive training BEHAVIORAL

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

Cognitive Training

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback; Cognitive Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

The study did not achieve the planned number of participants with usable data due to halt in the study due to COVID-19 pandemic.

Results Point of Contact

• Title: Hadi Hosseini
• Organization: Stanford University

hosseiny@stanford.edu

6507235798

Study Officials

• Hadi Hosseini

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 28, 2019
• Study Start: August 16, 2019
• Primary Completion: August 26, 2022
• Study Completion: September 14, 2022
• Last Updated: December 13, 2023
• Results First Posted: December 13, 2023

Record last verified: 2023-11

Locations

US (1)