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出境医 / 临床实验 / A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)

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

Study Description
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.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: Neurofeedback Behavioral: Cognitive training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Neurofeedback
The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.
 Behavioral: Neurofeedback
The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
Active Comparator: Cognitive Training
The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.
 Behavioral: Cognitive training
The Cognitive training group will receive computerized working memory training with performance feedback.
No Intervention: Waitlist
Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Outcome Measures
Primary Outcome Measures :
  1. Change in target frontal-parietal activity [ Time Frame: baseline, 3 and 6 weeks ]
    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.

  2. Change in working memory performance [ Time Frame: baseline, 3 and 6 weeks ]
    Accuracy in an N-back working memory task.


Secondary Outcome Measures :
  1. Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory t-score [ Time Frame: baseline and 6 weeks ]
    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.

  2. Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index score [ Time Frame: baseline and 6 weeks ]
    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

  3. Change in Conners 3rd Edition ADHD Index and Inattention t-score [ Time Frame: baseline and 6 weeks ]
    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 inattention problems.

  4. Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) composite score [ Time Frame: baseline and 6 weeks ]
    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 subtests range from 0 to 20. The composite score will be quantified using principal component analysis on accuracy across these subtests.


Other Outcome Measures:
  1. Change in Continuous Performance Test (CPT) accuracy [ Time Frame: baseline and 6 weeks ]
    CPT is standard test for measuring vigilance, sustained attention and inhibitory control.

  2. Change in California Verbal Learning Test - Children's version (CVLT-C) score [ Time Frame: baseline and 6 weeks ]
    CVLT-C test measures performance in learning and recalling verbal materials

  3. Change in Parent Stress Index 4th Edition (PSI-IV) [ Time Frame: baseline and 6 weeks ]
    PSI-IV evaluates the magnitude of stress in the parent-child system


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Hannah Fingerhut 650-724-2939 adhd_study@stanford.edu
Contact: Hadi Hosseini 6507235798 hosseiny@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Hannah Fingerhut    650-724-2939    adhd_study@stanford.edu   
Principal Investigator: Hadi Hosseini, PhD         
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Hadi Hosseini Stanford University
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Change in target frontal-parietal activity [ Time Frame: baseline, 3 and 6 weeks ]
    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.
  • Change in working memory performance [ Time Frame: baseline, 3 and 6 weeks ]
    Accuracy in an N-back working memory task.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Change in target frontal-parietal activity [ Time Frame: baseline, 3 and 6 weeks ]
    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.
  • Change in working memory performance [ Time Frame: baseline, 3, 6, and 12 weeks ]
    Accuracy in an N-back working memory task.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2020)
  • Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory t-score [ Time Frame: baseline and 6 weeks ]
    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.
  • Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index score [ Time Frame: baseline and 6 weeks ]
    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
  • Change in Conners 3rd Edition ADHD Index and Inattention t-score [ Time Frame: baseline and 6 weeks ]
    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 inattention problems.
  • Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) composite score [ Time Frame: baseline and 6 weeks ]
    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 subtests range from 0 to 20. The composite score will be quantified using principal component analysis on accuracy across these subtests.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory t-score [ Time Frame: baseline, 6, and 12 weeks ]
    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.
  • Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), Working Memory Index score [ Time Frame: baseline, 6, and 12 weeks ]
    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
  • Change in Conners 3rd Edition ADHD Index and Inattention t-score [ Time Frame: baseline, 6, and 12 weeks ]
    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 inattention problems.
  • Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) composite score [ Time Frame: baseline and 6 weeks ]
    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 subtests range from 0 to 20. The composite score will be quantified using principal component analysis on accuracy across these subtests.
Current Other Pre-specified Outcome Measures
 (submitted: January 28, 2020)
  • Change in Continuous Performance Test (CPT) accuracy [ Time Frame: baseline and 6 weeks ]
    CPT is standard test for measuring vigilance, sustained attention and inhibitory control.
  • Change in California Verbal Learning Test - Children's version (CVLT-C) score [ Time Frame: baseline and 6 weeks ]
    CVLT-C test measures performance in learning and recalling verbal materials
  • Change in Parent Stress Index 4th Edition (PSI-IV) [ Time Frame: baseline and 6 weeks ]
    PSI-IV evaluates the magnitude of stress in the parent-child system
Original Other Pre-specified Outcome Measures
 (submitted: June 26, 2019)
  • Change in NIH Toolbox Cognition composite score [ Time Frame: baseline, 6, and 12 weeks ]
    NIH Toolbox Cognition is a set of computerized assessments for measuring executive functions and memory. The composite score will be quantified using principal component analysis on standard scores of list-sort working memory test, flanker inhibitory control and attention test, and picture sequence memory test. Standard scores range from 50 to 150.
  • Change in Continuous Performance Test (CPT) accuracy [ Time Frame: baseline, 6, and 12 weeks ]
    CPT is standard test for measuring vigilance, sustained attention and inhibitory control.
  • Change in Rapid Automatized Naming Test (RAN) accuracy [ Time Frame: baseline, 6, and 12 weeks ]
    RAN is a standard test for measuring reading fluency
  • Change in California Verbal Learning Test - Children's version (CVLT-C) score [ Time Frame: baseline, 6, and 12 weeks ]
    CVLT-C test measures performance in learning and recalling verbal materials
  • Change in Parent Stress Index 4th Edition (PSI-IV) [ Time Frame: baseline and 6 weeks ]
    PSI-IV evaluates the magnitude of stress in the parent-child system
 
Descriptive Information
Brief Title  ICMJE A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Official Title  ICMJE A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ADHD
Intervention  ICMJE
  • Behavioral: Neurofeedback
    The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
  • Behavioral: Cognitive training
    The Cognitive training group will receive computerized working memory training with performance feedback.
Study Arms  ICMJE
  • Experimental: Neurofeedback
    The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.
    Intervention: Behavioral: Neurofeedback
  • Active Comparator: Cognitive Training
    The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab.
    Intervention: Behavioral: Cognitive training
  • No Intervention: Waitlist
    Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hannah Fingerhut 650-724-2939 adhd_study@stanford.edu
Contact: Hadi Hosseini 6507235798 hosseiny@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002167
Other Study ID Numbers  ICMJE 328066
R61MH119289 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadi Hosseini, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Hadi Hosseini Stanford University
PRS Account Stanford University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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