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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH119289 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback | Experimental | The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab. |
|
| Cognitive Training | Active Comparator | The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab. |
|
| Waitlist | No Intervention | Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Behavioral | The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score | 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. Lower T-scores on BRIEF indicates better working memory. T-score of 50 indicates the population mean with a standard deviation of 10. BRIEF working memory T-score of 65 and higher is indicative of deficits in working memory. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Continuous Performance Test (CPT) Accuracy | CPT is standard test for measuring vigilance, sustained attention and inhibitory control. | baseline and 6 weeks |
| Change in California Verbal Learning Test - Children's Version (CVLT-C) Score |
Inclusion criteria include:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadi Hosseini | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurofeedback (Phase I) | The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab. |
| FG001 | Waitlist (Phase I) | Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention. |
| FG002 | Cognitive Training (Phase II) | The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the protocol are included in the analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurofeedback (Phase I) | The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab. |
| BG001 | Waitlist (Phase I) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with usable data are included in the analysis | Posted | Mean | Standard Deviation | beta coefficient | baseline and 6 weeks |
|
Up to 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurofeedback (Phase I) | The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| feeling of heat in an eye | Eye disorders | Systematic Assessment | Unrelated to treatment |
The study did not achieve the planned number of participants with usable data due to halt in the study due to COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hadi Hosseini | Stanford University | 6507235798 | hosseiny@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2021 | Aug 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2023 | Aug 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Cognitive training | Behavioral | The Cognitive training group will receive computerized working memory training with performance feedback. |
|
| baseline and 6 weeks |
| Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score | 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 | baseline and 6 weeks |
| Change in Conners 3rd Edition ADHD Index Score | 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 elevated ADHD symptoms. Conners 3 ADHD index score of higher than 65 is indicative of ADHD diagnosis. | baseline and 6 weeks |
| Change in Conners 3rd Edition Inattention T-score | Conners 3 will be used to measure changes in clinical inattention symptoms. Conners 3 inattention t-score ranges from <30 to >100 with higher scores indicating larger impairment in attention. T-score of 50 indicates the population mean with a standard deviation of 10. Inattention t-score of 65 and higher is indicative of deficits in attention. | baseline and 6 weeks |
| Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score | 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 composite scores were quantified by averaging the scores across sub-scales. A positive change in composite score suggests increased ability in subtest domains. The composite score below 8 suggest deficits. The composite scores range from 0 to 20; lower scores correspond to more deficits, and higher scores correspond to more abilities. | baseline and 6 weeks |
CVLT-C test measures performance in learning and recalling verbal materials
| baseline and 6 weeks |
| Change in Parent Stress Index 4th Edition (PSI-IV) | PSI-IV evaluates the magnitude of stress in the parent-child system | baseline and 6 weeks |
Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab.
| OG001 | Waitlist (Phase I) | Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention. |
|
|
| Primary | Change in Working Memory Performance | Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli. | Participants with usable data are included in the analysis. | Posted | Mean | Standard Deviation | percent change in accuracy | baseline and 6 weeks |
|
|
|
| Secondary | Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score | 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. Lower T-scores on BRIEF indicates better working memory. T-score of 50 indicates the population mean with a standard deviation of 10. BRIEF working memory T-score of 65 and higher is indicative of deficits in working memory. | Participants with usable data are included in the analysis. | Posted | Mean | Standard Deviation | t-score | baseline and 6 weeks |
|
|
|
| Secondary | Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score | 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 | Participants with usable data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 weeks |
|
|
|
| Secondary | Change in Conners 3rd Edition ADHD Index Score | 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 elevated ADHD symptoms. Conners 3 ADHD index score of higher than 65 is indicative of ADHD diagnosis. | Participants with usable data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline and 6 weeks |
|
|
|
| Secondary | Change in Conners 3rd Edition Inattention T-score | Conners 3 will be used to measure changes in clinical inattention symptoms. Conners 3 inattention t-score ranges from <30 to >100 with higher scores indicating larger impairment in attention. T-score of 50 indicates the population mean with a standard deviation of 10. Inattention t-score of 65 and higher is indicative of deficits in attention. | Participants with usable data were included in the analysis. | Posted | Mean | Standard Deviation | t-score | baseline and 6 weeks |
|
|
|
| Secondary | Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score | 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 composite scores were quantified by averaging the scores across sub-scales. A positive change in composite score suggests increased ability in subtest domains. The composite score below 8 suggest deficits. The composite scores range from 0 to 20; lower scores correspond to more deficits, and higher scores correspond to more abilities. | participants with usable data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 weeks |
|
|
|
| Other Pre-specified | Change in Continuous Performance Test (CPT) Accuracy | CPT is standard test for measuring vigilance, sustained attention and inhibitory control. | Not Posted | baseline and 6 weeks | Participants |
| Other Pre-specified | Change in California Verbal Learning Test - Children's Version (CVLT-C) Score | CVLT-C test measures performance in learning and recalling verbal materials | Not Posted | baseline and 6 weeks | Participants |
| Other Pre-specified | Change in Parent Stress Index 4th Edition (PSI-IV) | PSI-IV evaluates the magnitude of stress in the parent-child system | Not Posted | baseline and 6 weeks | Participants |
| 0 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | Waitlist (Phase I) | Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |