Online Neuroplasticity Training for Remediation of ADHD in Adolescent Children (ONTRAC)

NCT01772485 | Completed DMC

• 2 other identifiers: ADHD-India5R24TW007988-05
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 clinical population in New Delhi, India.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• CGIC 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

Other Outcomes (4)

• Test of Variables of Attention (TOVA), visual form, change from baseline

  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

  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

  Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention

Study Arms (2)

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.

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.

Behavioral: Active Control

Interventions

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.

Cognitive Training

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.

Active Control

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Posit Science Corporation: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (10)

• 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.

  PMID: 14649473 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.

  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.

  PMID: 8539604 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.

  PMID: 16888038 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.

  PMID: 19220558 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.

  PMID: 20838474 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.

  PMID: 19448187 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.

  PMID: 17995483 BACKGROUND

• 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.

  PMID: 27070409 RESULT

Related Links

• Published paper with study results

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jyoti Mishra, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 21, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

IN (1)