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

NCT ID: NCT04002167

Last Updated: 2023-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-16

Study Completion Date

2022-09-14

Brief Summary

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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

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Conditions

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ADHD

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Neurofeedback

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

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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 12 sessions of computerized cognitive intervention in the lab.

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

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

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neurofeedback

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

Intervention Type BEHAVIORAL

Cognitive training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Hadi Hosseini

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hadi Hosseini

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R61MH119289

Identifier Type: NIH

Identifier Source: secondary_id

View Link

328066

Identifier Type: -

Identifier Source: org_study_id