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

Stanford University

Status: Completed

Conditions: ADHD

Treatments: Behavioral: Cognitive training; Behavioral: Neurofeedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04002167

328066

R61MH119289 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 3 patient groups

Neurofeedback

Experimental group

Description:

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

Treatment:

Behavioral: Neurofeedback

Cognitive Training

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive training

Waitlist

No Intervention group

Description:

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