Attention Deficit Hyperactivity DisorderNCT01772485
Online Neuroplasticity Training for Remediation of ADHD in Adolescent Children (ONTRAC)
A study testing Cognitive Training in people with Attention Deficit Hyperactivity Disorder, run by Posit Science Corporation at 1 site in India.
Trial summary
This project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based internet-deliverable cognitive training program, which specifically targets the treatment of core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity Disorder (ADHD/ADD), to be tested in a… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2013to May 2015
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of ADHD as verified by a semi-structured clinical interview using the Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia) interview schedule for school-aged children and SWAN rating scale (Polderman et al., 2007)
- Access to an internet connected computer for online training
Who cannot join
- Fulfilling criteria for diagnosis of clinically significant conduct disorder
- Autistic or Asperger's syndrome
- Depression
- History of seizure disorder or seizure episodes over the last 2 years
- Motor/ perceptual handicap that prevents computer use
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Double Blind Randomized Controlled Trial Evaluation of a Novel Brain Plasticity-based Training Program for the Remediation of Cognitive Deficits in Adolescents With ADHD in New Delhi, India
This project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based internet-deliverable cognitive training program, which specifically targets the treatment of core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity Disorder (ADHD/ADD), to be tested in a clinical population in New Delhi, India.
Read the detailed description
Children diagnosed with ADHD, now comprising nearly 9% of American children and a similar proportion of Indian children, are at risk for failure or drop out from school, prone to developing addictions, having driving accidents, committing felonies later in life and suffer from an overall poor quality of life. Rescuing the cognitive faculties of these children is thus of immediate importance, not only from the perspective of the individual, but also from the urgency posed by the large socio-economic and health-care burdens associated with this disorder.
The investigators have recently developed an efficient, state-of-the-art, web-based, cost-effective and highly scalable cognitive training program for ADHD ('Rewired') that can translate into real-life functional gains for the affected children. The novel program targets the fundamental neurobehavioral/ cognitive deficits identified in this disorder. These include deficits in general alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information - a panoply of problems that have not been comprehensively addressed by any intervention in this population to-date.
Recent advances in neuroscientific research have provided key insight into the application of brain-based methods to behavioral training to drive substantial functional gains. This research forms the mechanistic basis of the development approach. Moreover, the principal exercise forms in the training program have independently demonstrated significant benefits in other attentionally-impaired populations towards remediation of the core cognitive deficits that intersect with the deficient domains in ADHD. Here, the core exercise forms have been tailored and elaborated into a comprehensive program suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD. The investigators propose to validate the usability and feasibility of this novel training program in a randomized controlled trial (RCT) setting. It is hypothesized that improvements in the specific core cognitive domains deficient in ADHD, shall translate to better overall cognitive function in daily life as well as significant reduction of ADHD symptom severity. The current intervention ultimately projects a better life quality for children with ADHD, and has the potential to substantially reduce the large personal, familial, societal and economic burden associated with the disorder worldwide.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Cognitive Training, Active Control
- 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.
Cognitive TrainingBehavioural
The training comprises a suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD addressing deficits in core cognitive domains of alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information.
Active ControlBehavioural
Participants will engage in any 4 of 13 suite games (visual tiled puzzles, word games etc.) from the Hoyle Puzzle and Board games program. Suite games are randomly assigned in each session.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | Training group participants will engage in 30 hours of at-home online training on the novel neuroplasticity-based cognitive training program ('Rewired') in 30 minute sessions completed approximately 3-5 days per week, for a total training period lasting 12-20 weeks. Both visual and auditory exercise forms will be practiced daily. Level progression criteria will be flexibly set to assure that almost all individuals can reach them in a reasonable time. Training compliance and performance data (accuracies and reaction times) will be continuously monitored remotely, and analyzed over secure online servers to assure that subjects are completing their training as scheduled and to deal with any unexpected road-blocks in training. Receives: Behavioral: Cognitive Training |
| Active Control | Active comparator | The active control group shall engage in an at-home computer game suite, as used in a prior cognitive training trial in a psychiatric population (Fisher et al., 2009), for the same number of hours as the training group to control for the effects of computer exposure and interaction, contact with clinical research personnel and monetary rewards. Compliance will be monitored via an online data portal. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD rating scale IV change from baseline
Measured: Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
Secondary outcomes (1)
CGIC change from baseline
Clinical Global Impressions of Change
Measured: Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Jyoti Mishra, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772485
- Sponsor's protocol ID
- ADHD-India
- Other IDs
- 5R24TW007988-05
- Status last verified
- Sep 2019
- First submitted
- 14 Jan 2013
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mukhopadhyay M, Misra S, Mitra T, Niyogi P. Attention deficit hyperactivity disorder. Indian J Pediatr. 2003 Oct;70(10):789-92. doi: 10.1007/BF02723796.
PubMed 14649473Merzenich MM , Recanzone G, Jenkins W (1991) How the brain functionally rewires itself, in Natural and Artificial Parallel Computations M. Arbib and J.A. Robinson, ed. New York.: MIT Press.
Merzenich MM , deCharms C (1996) Neural representations, experience and change. in The Mind-Brain Continuum: R. Llinas and P. Churchland, Editors :p. 61-81.
Tallal P, Miller SL, Bedi G, Byma G, Wang X, Nagarajan SS, Schreiner C, Jenkins WM, Merzenich MM. Language comprehension in language-learning impaired children improved with acoustically modified speech. Science. 1996 Jan 5;271(5245):81-4. doi: 10.1126/science.271.5245.81.
PubMed 8539604Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
PubMed 16888038Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
PubMed 19220558Degutis JM, Van Vleet TM. Tonic and phasic alertness training: a novel behavioral therapy to improve spatial and non-spatial attention in patients with hemispatial neglect. Front Hum Neurosci. 2010 Aug 24;4:60. doi: 10.3389/fnhum.2010.00060. eCollection 2010.
PubMed 20838474Fisher M, Holland C, Merzenich MM, Vinogradov S. Using neuroplasticity-based auditory training to improve verbal memory in schizophrenia. Am J Psychiatry. 2009 Jul;166(7):805-11. doi: 10.1176/appi.ajp.2009.08050757. Epub 2009 May 15.
PubMed 19448187Polderman TJ, Derks EM, Hudziak JJ, Verhulst FC, Posthuma D, Boomsma DI. Across the continuum of attention skills: a twin study of the SWAN ADHD rating scale. J Child Psychol Psychiatry. 2007 Nov;48(11):1080-7. doi: 10.1111/j.1469-7610.2007.01783.x.
PubMed 17995483Mishra J, Sagar R, Joseph AA, Gazzaley A, Merzenich MM. Training sensory signal-to-noise resolution in children with ADHD in a global mental health setting. Transl Psychiatry. 2016 Apr 12;6(4):e781. doi: 10.1038/tp.2016.45.
PubMed 27070409
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Controlled Trial Evaluation of a Novel Brain Plasticity-based Training Program for the Remediation of Cognitive Deficits in Adolescents With ADHD in New Delhi, India
- ClinicalTrials.gov ID
- NCT01772485
- Acronym / sponsor ID
- ADHD-India
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Jan 2013 (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 project shall rigorously evaluate the effectiveness of a novel, neuroplasticity-based internet-deliverable cognitive training program, which specifically targets the treatment of core cognitive dysfunctions observed in adolescents with Attention Deficit Hyperactivity Disorder (ADHD/ADD), to be tested in a clinical population in New Delhi, India.
Detailed description
Children diagnosed with ADHD, now comprising nearly 9% of American children and a similar proportion of Indian children, are at risk for failure or drop out from school, prone to developing addictions, having driving accidents, committing felonies later in life and suffer from an overall poor quality of life. Rescuing the cognitive faculties of these children is thus of immediate importance, not only from the perspective of the individual, but also from the urgency posed by the large socio-economic and health-care burdens associated with this disorder.
The investigators have recently developed an efficient, state-of-the-art, web-based, cost-effective and highly scalable cognitive training program for ADHD ('Rewired') that can translate into real-life functional gains for the affected children. The novel program targets the fundamental neurobehavioral/ cognitive deficits identified in this disorder. These include deficits in general alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information - a panoply of problems that have not been comprehensively addressed by any intervention in this population to-date.
Recent advances in neuroscientific research have provided key insight into the application of brain-based methods to behavioral training to drive substantial functional gains. This research forms the mechanistic basis of the development approach. Moreover, the principal exercise forms in the training program have independently demonstrated significant benefits in other attentionally-impaired populations towards remediation of the core cognitive deficits that intersect with the deficient domains in ADHD. Here, the core exercise forms have been tailored and elaborated into a comprehensive program suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD. The investigators propose to validate the usability and feasibility of this novel training program in a randomized controlled trial (RCT) setting. It is hypothesized that improvements in the specific core cognitive domains deficient in ADHD, shall translate to better overall cognitive function in daily life as well as significant reduction of ADHD symptom severity. The current intervention ultimately projects a better life quality for children with ADHD, and has the potential to substantially reduce the large personal, familial, societal and economic burden associated with the disorder worldwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingTraining group participants will engage in 30 hours of at-home online training on the novel neuroplasticity-based cognitive training program ('Rewired') in 30 minute sessions completed approximately 3-5 days per week, for a total training period lasting 12-20 weeks. Both visual and auditory exercise forms will be practiced daily. Level progression criteria will be flexibly set to assure that almost all individuals can reach them in a reasonable time. Training compliance and performance data (accuracies and reaction times) will be continuously monitored remotely, and analyzed over secure online servers to assure that subjects are completing their training as scheduled and to deal with any unexpected road-blocks in training. |
| Active Control | Active comparator | Behavioral: Active ControlThe active control group shall engage in an at-home computer game suite, as used in a prior cognitive training trial in a psychiatric population (Fisher et al., 2009), for the same number of hours as the training group to control for the effects of computer exposure and interaction, contact with clinical research personnel and monetary rewards. Compliance will be monitored via an online data portal. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of ADHD as verified by a semi-structured clinical interview using the Kiddie-SADS (Schedule for Affective Disorders and Schizophrenia) interview schedule for school-aged children and SWAN rating scale (Polderman et al., 2007)
- Access to an internet connected computer for online training
Key exclusion criteria (5 listed)
- Fulfilling criteria for diagnosis of clinically significant conduct disorder
- Autistic or Asperger's syndrome
- Depression
- History of seizure disorder or seizure episodes over the last 2 years
- Motor/ perceptual handicap that prevents computer use
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 |
|---|---|---|
| Cognitive TrainingThe training comprises a suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD addressing deficits in core cognitive domains of alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information. | Behavioural | Cognitive Training |
| Active ControlParticipants will engage in any 4 of 13 suite games (visual tiled puzzles, word games etc.) from the Hoyle Puzzle and Board games program. Suite games are randomly assigned in each session. | Behavioural | Active Control |
Primary outcome
ADHD rating scale IV change from baseline
Time frame: Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention
1 secondary outcome
CGIC change from baseline
Time frame: Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-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 12 Sep 2019.
- Background: PubMed 14649473Mukhopadhyay M, Misra S, Mitra T, Niyogi P. Attention deficit hyperactivity disorder. Indian J Pediatr. 2003 Oct;70(10):789-92. doi: 10.1007/BF02723796.
- BackgroundMerzenich MM , Recanzone G, Jenkins W (1991) How the brain functionally rewires itself, in Natural and Artificial Parallel Computations M. Arbib and J.A. Robinson, ed. New York.: MIT Press.
- BackgroundMerzenich MM , deCharms C (1996) Neural representations, experience and change. in The Mind-Brain Continuum: R. Llinas and P. Churchland, Editors :p. 61-81.
- Background: PubMed 8539604Tallal P, Miller SL, Bedi G, Byma G, Wang X, Nagarajan SS, Schreiner C, Jenkins WM, Merzenich MM. Language comprehension in language-learning impaired children improved with acoustically modified speech. Science. 1996 Jan 5;271(5245):81-4. doi: 10.1126/science.271.5245.81.
- Background: PubMed 16888038Mahncke HW, Connor BB, Appelman J, Ahsanuddin ON, Hardy JL, Wood RA, Joyce NM, Boniske T, Atkins SM, Merzenich MM. Memory enhancement in healthy older adults using a brain plasticity-based training program: a randomized, controlled study. Proc Natl Acad Sci U S A. 2006 Aug 15;103(33):12523-8. doi: 10.1073/pnas.0605194103. Epub 2006 Aug 3.
- Background: PubMed 19220558Smith GE, Housen P, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Zelinski EM. A cognitive training program based on principles of brain plasticity: results from the Improvement in Memory with Plasticity-based Adaptive Cognitive Training (IMPACT) study. J Am Geriatr Soc. 2009 Apr;57(4):594-603. doi: 10.1111/j.1532-5415.2008.02167.x. Epub 2009 Feb 9.
- Background: PubMed 20838474Degutis JM, Van Vleet TM. Tonic and phasic alertness training: a novel behavioral therapy to improve spatial and non-spatial attention in patients with hemispatial neglect. Front Hum Neurosci. 2010 Aug 24;4:60. doi: 10.3389/fnhum.2010.00060. eCollection 2010.
- Background: PubMed 19448187Fisher M, Holland C, Merzenich MM, Vinogradov S. Using neuroplasticity-based auditory training to improve verbal memory in schizophrenia. Am J Psychiatry. 2009 Jul;166(7):805-11. doi: 10.1176/appi.ajp.2009.08050757. Epub 2009 May 15.
- Background: PubMed 17995483Polderman TJ, Derks EM, Hudziak JJ, Verhulst FC, Posthuma D, Boomsma DI. Across the continuum of attention skills: a twin study of the SWAN ADHD rating scale. J Child Psychol Psychiatry. 2007 Nov;48(11):1080-7. doi: 10.1111/j.1469-7610.2007.01783.x.
- Results publication: PubMed 27070409Mishra J, Sagar R, Joseph AA, Gazzaley A, Merzenich MM. Training sensory signal-to-noise resolution in children with ADHD in a global mental health setting. Transl Psychiatry. 2016 Apr 12;6(4):e781. doi: 10.1038/tp.2016.45.
- Published paper with study resultsLink provided by the sponsor.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Jyoti Mishra, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Attention Deficit Hyperactivity Disorder, run by Posit Science Corporation at 1 site in India.
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 2 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 12 Sep 2019. 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 India. 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?
ADHD rating scale IV change from baseline (time frame: Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772485, which also lists 10 linked publications.
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 12 Sep 2019.