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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Posit Science Corporation
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Posit Science Corporation
ClinicalTrials.gov Identifier:
NCT01772485
First received: January 14, 2013
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Behavioral: Cognitive Training
Behavioral: Active Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Posit Science Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Clinical Global Impressions of Change


Other Outcome Measures:
  • Test of Variables of Attention (TOVA), visual form, change from baseline [ Time Frame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention. ] [ Designated as safety issue: No ]
    for assessment of sustained attention and impulsive response control

  • Spatial Sternberg Task change from baseline [ Time Frame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention ] [ Designated as safety issue: No ]
    for assessment of visual working memory

  • Verbal Sternberg Task change from baseline [ Time Frame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention ] [ Designated as safety issue: No ]
    for assessment of verbal working memory

  • Stroop task change from baseline [ Time Frame: Change from baseline at completion of 30 hours of practice on assigned intervention and at 3 months follow-up post-intervention ] [ Designated as safety issue: No ]
    for assessment of executive function


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Training
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
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 Comparator: Active Control
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
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772485

Contacts
Contact: Rajesh Sagar, MD 91-11-26593644 rsagar29@gmail.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Rajesh Sagar, MD    91-11-26593644    rsagar29@gmail.com   
Principal Investigator: Rajesh Sagar, MD         
Sub-Investigator: Angela Joseph, MS         
Sponsors and Collaborators
Posit Science Corporation
Investigators
Principal Investigator: Jyoti Mishra, PhD Brain Plasticity Institute
  More Information

Publications:
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT01772485     History of Changes
Other Study ID Numbers: ADHD-India, 5R24TW007988-05
Study First Received: January 14, 2013
Last Updated: May 13, 2013
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014