Stanford, California 94305

  • ADHD

Purpose:

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.


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


Study is Available At:


Original ID:

328066


NCT ID:

NCT04002167


Secondary ID:

R61MH119289


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

7 Years


Maximum Age:

11 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Hadi Hosseini
Principal Investigator
Stanford University
Primary Contact:Hannah Fingerhut
650-724-2939
adhd_study@stanford.edu
Backup Contact:Hadi Hosseini
6507235798
hosseiny@stanford.edu

Study Dates

Start Date:August 16, 2019
Completion Date:January 31, 2022
Completion Type:Anticipated
Primary Completion Date:December 31, 2021
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 3, 2021
First Received Date:June 24, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in target frontal-parietal activity
Time Frame:baseline, 3 and 6 weeks
Safety Issues:False
Description:Increased activity in the target frontal-parietal network measured by functional MRI (fMRI) and functional near infrared spectroscopy (fNIRS) during an N-back working memory task.
Outcome Type:Primary Outcome
Measure:Change in working memory performance
Time Frame:baseline, 3 and 6 weeks
Safety Issues:False
Description:Accuracy in an N-back working memory task.
Outcome Type:Secondary Outcome
Measure:Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory t-score
Time Frame:baseline and 6 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index score
Time Frame:baseline and 6 weeks
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change in Conners 3rd Edition ADHD Index and Inattention t-score
Time Frame:baseline and 6 weeks
Safety Issues:False
Description: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 more ADHD symptoms. Inattention t-score ranges from <30 to >100 with higher scores indicating more ina
Outcome Type:Secondary Outcome
Measure:Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) composite score
Time Frame:baseline and 6 weeks
Safety Issues:False
Description: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 scaled scores on all su

Study Interventions

Intervention Type:Behavioral
Name:Neurofeedback
Description:The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
Arm Name:Neurofeedback
Intervention Type:Behavioral
Name:Cognitive training
Description:The Cognitive training group will receive computerized working memory training with performance feedback.
Arm Name:Cognitive Training

Study Arms

Study Arm Type:Experimental
Arm Name:Neurofeedback
Description:The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.
Study Arm Type:Active Comparator
Arm Name:Cognitive Training
Description:The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.
Study Arm Type:No Intervention
Arm Name:Waitlist
Description:Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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