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| ID | Type | Description | Link |
|---|---|---|---|
| 5R24TW007988-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD rating scale IV change from baseline | Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| CGIC change from baseline | Clinical Global Impressions of Change | Change from baseline at completion of 15 hours and 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Test of Variables of Attention (TOVA), visual form, change from baseline | for assessment of sustained attention and impulsive response control | Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention. |
| Spatial Sternberg Task change from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jyoti Mishra, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14649473 | Background | 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. | |
| Background | Merzenich 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. | ||
| Background | Merzenich MM , deCharms C (1996) Neural representations, experience and change. in The Mind-Brain Continuum: R. Llinas and P. Churchland, Editors :p. 61-81. | ||
| 8539604 |
| Label | URL |
|---|---|
| Published paper with study results | View source |
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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 |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Active Control | Behavioral | 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. |
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for assessment of visual working memory |
| Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention |
| Verbal Sternberg Task change from baseline | for assessment of verbal working memory | Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention |
| Stroop task change from baseline | for assessment of executive function | Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention |
| Background |
| 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. |
| 16888038 | Background | Mahncke 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. |
| 19220558 | Background | Smith 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. |
| 20838474 | Background | Degutis 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. |
| 19448187 | Background | Fisher 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. |
| 17995483 | Background | Polderman 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. |
| 27070409 | Result | Mishra 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. |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |