ADHDNCT02642055
Efficacy of Neuro+ Attention Training
A study testing Neuro+ Attention Training and Treatment as Usual in people with ADHD, run by Neuro+ at 1 site in United States.
Trial summary
This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in improving attention skills in children. Half of participants will receive the Neuro+ intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for the same period. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- Neuro+ Attention Training and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8 to 13 at the time of parental informed consent.
- Confirmed ADHD diagnosis at clinic
- No usage of ADHD drugs in past 30 days, or stable on current drug regimen for at least 30 days. Drugs include: Pre specified, oral psychostimulants, including ADDERALL XR® [mixed salts of a single-entity amphetamine product], VYVANSE® [lisdexamfetamine dimesylate], CONCERTA® [methylphenidate HCl], FOCALIN XR® [dexmethylphenidate HCl], RITALIN LA® [methylphenidate HCl extended-release], METADATE CD® [methylphenidate HCl, USP], or other FDA-approved equivalents.
- Ability to follow written and verbal instructions (English)
- Girls or Boys
- Functioning at an age-appropriate level intellectually.
- Ability to comply with all the testing and requirements.
Who cannot join
- Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
- Motor condition that prevents game playing.
- Recent history (within the past 6 months) of suspected substance abuse or dependence.
- History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder.
- Taken part in a clinical trial within 30 days prior to screening.
- Diagnosis of color blindness.
- Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
- Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare
Raleigh, North Carolina, 27609
About this study
Official title: Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial
This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in improving attention skills in children. Half of participants will receive the Neuro+ intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for the same period. We expect those receiving the Neuro+ intervention to see significant improvements in ADHD symptoms relative to the TAU controls.
Read the detailed description
Neuro+ a non-pharmacological intervention that targets the underlying neural signatures and cognitive deficits which are assumed to mediate attention pathways. Targeting those underlying areas could reduce ADHD symptoms and potentially lead to greater transfer and generalization to functioning in the classroom and every day life.
Neuro+ combines neurofeedback, biofeedback, and go/no-go training protocols embedded in a training video game to help develop and improve attention skills. The protocols function as follows:
Neurofeedback: Users wear a dry, wireless, easy-to-use EEG headset that interfaces with computer software to provide feedback on their level of brain activation, or focus. Users must focus in order to advance through the training game.
Motion-biofeedback: Accelerometers in the headset send data on users' movement to the training game, such that users must maintain complete control of their bodies and remain absolutely still in order to advance through the game and avoid costly point penalties.
Go/no-go training: To practice impulse control, users will be challenged with adaptive "go/no-go tasks," requiring them to quickly and accurately respond to target stimuli and ignore distractions, with the tasks becoming more difficult as the user improves.
- Conditions
- ADHD
- Being tested
- Neuro+ Attention Training, Treatment as Usual
- Keywords
- ADHD, Neurofeedback, Biofeedback, Neuro+, Go/no-go, Attention training
- 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.
Neuro+ Attention TrainingBehavioural
Attention training program with Neuro+ software
Treatment as UsualOther
Continuation of current ADHD treatment
| Study group | Role | What they receive |
|---|---|---|
| Neuro+ Intervention | Experimental | 30 sessions (900 minutes) of Neuro+ Attention Training administered over 10 weeks. Receives: Behavioral: Neuro+ Attention Training |
| Treatment as Usual | Active comparator | Continuation of current treatment for ADHD Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD symptoms with Quotient ADHD System assessment
Assessments to be conducted with the Quotient ADHD System
Measured: At screening and at final clinical visit within 1 week following intervention
Change in assessment of ADHD symptoms with Conners 3-Parent rating scale
Assessments to be conducted with the Conners 3-Parent rating scale
Measured: At screening and at final clinical visit within 1 week following intervention
Incidence of adverse events
Self-reported incidence of adverse events
Measured: As reported by subjects at final clinical visit, which occurs within 1 week following intervention.
Secondary outcomes (1)
Self-reported convenience ratings of Neuro+ intervention
As evaluated on a Likert scale, the extent to which subjects and parents found the Neuro+ intervention convenient/easy-to-use
Measured: At final clinical visit, within 1 week following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuro+
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandeep Vaishnavi, MD, PhD, Principal investigator, Carolina Partners in Mental HealthCare, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642055
- Sponsor's protocol ID
- NEURO+001
- Status last verified
- May 2016
- First submitted
- 18 Dec 2015
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial
- ClinicalTrials.gov ID
- NCT02642055
- Acronym / sponsor ID
- NEURO+001
- Conditions
- ADHD
- Keywords
- ADHD, Neurofeedback, Biofeedback, Neuro+, Go/no-go, Attention training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neuro+Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in improving attention skills in children. Half of participants will receive the Neuro+ intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for the same period. We expect those receiving the Neuro+ intervention to see significant improvements in ADHD symptoms relative to the TAU controls.
Detailed description
Neuro+ a non-pharmacological intervention that targets the underlying neural signatures and cognitive deficits which are assumed to mediate attention pathways. Targeting those underlying areas could reduce ADHD symptoms and potentially lead to greater transfer and generalization to functioning in the classroom and every day life.
Neuro+ combines neurofeedback, biofeedback, and go/no-go training protocols embedded in a training video game to help develop and improve attention skills. The protocols function as follows:
Neurofeedback: Users wear a dry, wireless, easy-to-use EEG headset that interfaces with computer software to provide feedback on their level of brain activation, or focus. Users must focus in order to advance through the training game.
Motion-biofeedback: Accelerometers in the headset send data on users' movement to the training game, such that users must maintain complete control of their bodies and remain absolutely still in order to advance through the game and avoid costly point penalties.
Go/no-go training: To practice impulse control, users will be challenged with adaptive "go/no-go tasks," requiring them to quickly and accurately respond to target stimuli and ignore distractions, with the tasks becoming more difficult as the user improves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro+ Intervention | Experimental | Behavioral: Neuro+ Attention Training30 sessions (900 minutes) of Neuro+ Attention Training administered over 10 weeks. |
| Treatment as Usual | Active comparator | Other: Treatment as UsualContinuation of current treatment for ADHD |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 8 to 13 at the time of parental informed consent.
- Confirmed ADHD diagnosis at clinic
- No usage of ADHD drugs in past 30 days, or stable on current drug regimen for at least 30 days. Drugs include: Pre specified, oral psychostimulants, including ADDERALL XR® [mixed salts of a single-entity amphetamine product], VYVANSE® [lisdexamfetamine dimesylate], CONCERTA® [methylphenidate HCl], FOCALIN XR® [dexmethylphenidate HCl], RITALIN LA® [methylphenidate HCl extended-release], METADATE CD® [methylphenidate HCl, USP], or other FDA-approved equivalents.
- Ability to follow written and verbal instructions (English)
- Girls or Boys
Key exclusion criteria (8 listed)
- Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
- Motor condition that prevents game playing.
- Recent history (within the past 6 months) of suspected substance abuse or dependence.
- History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder.
- Taken part in a clinical trial within 30 days prior to screening.
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 |
|---|---|---|
| Neuro+ Attention TrainingAttention training program with Neuro+ software | Behavioural | Neuro+ Intervention |
| Treatment as UsualContinuation of current ADHD treatment | Other | Treatment as Usual |
Primary outcome
Change in ADHD symptoms with Quotient ADHD System assessment
Time frame: At screening and at final clinical visit within 1 week following intervention
Assessments to be conducted with the Quotient ADHD System
Change in assessment of ADHD symptoms with Conners 3-Parent rating scale
Time frame: At screening and at final clinical visit within 1 week following intervention
Assessments to be conducted with the Conners 3-Parent rating scale
Incidence of adverse events
Time frame: As reported by subjects at final clinical visit, which occurs within 1 week following intervention.
Self-reported incidence of adverse events
1 secondary outcome
Self-reported convenience ratings of Neuro+ intervention
Time frame: At final clinical visit, within 1 week following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Sandeep Vaishnavi, MD, PhD principal investigator
Carolina Partners in Mental HealthCare, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro+ Attention Training and Treatment as Usual in people with ADHD, run by Neuro+ 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 7 inclusion and 8 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 21 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 ADHD symptoms with Quotient ADHD System assessment (time frame: At screening and at final clinical visit within 1 week following intervention). The study lists 3 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 21 Dec 2016.