ADHDNCT04002167
A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Neurofeedback and Cognitive training in people with ADHD, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- Neurofeedback and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2019to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory
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.
- Conditions
- ADHD
- Being tested
- Neurofeedback, Cognitive training
- Keywords
- ADHD, Working memory, functional near infrared spectroscopy (fNIRS), magnetic resonance imaging (MRI), Neurofeedback, Cognitive training, Neuromonitoring
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
Cognitive trainingBehavioural
The Cognitive training group will receive computerized working memory training with performance feedback.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | The Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab. Receives: Behavioral: Neurofeedback |
| Cognitive Training | Active comparator | The Cognitive Training group will receive 12 sessions of computerized cognitive intervention in the lab. Receives: Behavioral: Cognitive training |
| Waitlist | No intervention | Both Neurofeedback and Cognitive Training groups will be assigned to waitlist before starting the corresponding intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and 6 weeks
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start16 Aug 2019
- Primary completion26 Aug 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Hadi Hosseini, Stanford University
- Investigators
- Hadi Hosseini, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002167
- Sponsor's protocol ID
- 328066
- Other IDs
- R61MH119289
- Status last verified
- Nov 2023
- First submitted
- 24 Jun 2019
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Neuromonitoring Guided Cognitive Intervention for Targeted Enhancement of Working Memory
- ClinicalTrials.gov ID
- NCT04002167
- Acronym / sponsor ID
- 328066
- Conditions
- ADHD
- Keywords
- ADHD, Working memory, functional near infrared spectroscopy (fNIRS), magnetic resonance imaging (MRI), Neurofeedback, Cognitive training, Neuromonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Aug 2019 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Behavioral: NeurofeedbackThe Neurofeedback group will receive 12 sessions of computerized cognitive intervention combined with neurofeedback in the lab. |
| Cognitive Training | Active comparator | Behavioral: Cognitive trainingThe 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackThe Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback. | Behavioural | Neurofeedback |
| Cognitive trainingThe Cognitive training group will receive computerized working memory training with performance feedback. | Behavioural | Cognitive Training |
Primary outcome
Change in Target Frontal-parietal Activity
Time frame: baseline and 6 weeks
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.
Change in Working Memory Performance
Time frame: baseline and 6 weeks
Accuracy in an N-back working memory task was calculated as the percentage of correct responses to target stimuli.
5 secondary outcomes
Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score
Time frame: baseline and 6 weeks
Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score
Time frame: baseline and 6 weeks
Change in Conners 3rd Edition ADHD Index Score
Time frame: baseline and 6 weeks
Change in Conners 3rd Edition Inattention T-score
Time frame: baseline and 6 weeks
Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score
Time frame: baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadi Hosseini principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback and Cognitive training in people with ADHD, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Target Frontal-parietal Activity (time frame: baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.