Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome

NCT02732496 | Completed

• 1 other identifier: 2015P002512
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting working memory in 30 children with comorbid Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).

Conditions

Attention-Deficit/Hyperactivity Disorder; Tourette Syndrome

Keywords

Attention-Deficit/Hyperactivity Disorder; Tourette Syndrome; Working Memory Training

Outcome Measures

Primary Outcomes (4)

• Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  The SWM subtest assesses working memory.

  3 months

• Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  The SSP subtest assesses working memory.

  3 months

• The Working Memory Index from the Behavior Rating Inventory of Executive Function (BRIEF)

  Parent and teacher ratings on the Working Memory Index of the BRIEF assess working memory.

  3 months

• The Behavioral Regulation Index from the Behavior Rating Inventory of Executive Function (BRIEF)

  Parent and teacher ratings on the Behavioral Regulation Index of the BRIEF assess working memory.

  3 months

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Targeted Cognitive Training (TCT)

Behavioral: Targeted Cognitive Training (TCT)

Youth Appropriate Online Games

PLACEBO COMPARATOR

Engaging games not designed to improve cognition

Other: Youth Appropriate Online Games

Interventions

Targeted Cognitive Training (TCT) BEHAVIORAL

The instructors have selected a set of computer exercises designed to specifically target working memory, which is a cognitive construct relevant to ADHD and Tourette Syndrome. The tasks were designed to benefit subjects through principles of learning-dependent plasticity.

Cognitive Training

Youth Appropriate Online Games OTHER

Engaging games not designed to improve cognition.

Youth Appropriate Online Games

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The investigators will include youth who have undergone neuropsychological testing in the prior 3 years.

You may not qualify if:

• The investigators will exclude patients with intellectual disability in order to more directly extend the prior literature to the ADHD+TS population.
• The investigators will exclude patients with severe tics as evidenced by a score of \> 30 on the clinician administered Yale Global Tic Severity Scale (YGTSS).
• The investigators will exclude patients with moderate to severe Obsessive Compulsive Disorder (OCD) symptoms, as evidenced by a score of \>30 on the clinician administered Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS).
• The investigators will exclude patients treated with neuroleptics, given that these medications can be cognitively dulling and sedating and potentially lead to secondary working memory impairments.
• The investigators will exclude families who do not have a computer with an internet connection in their homes, and in which neither a parent nor the child has an email address to receive study related communications.
• The investigators will exclude families who anticipate or are likely to have a change in therapeutic treatments (i.e., psychotherapy or psychopharmacology) during the time frame of the trial.
• NOTE: Patients treated with ADHD medications will not be excluded, but medications will be recorded for covariate analysis.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Louis V. Gerstner III Research Scholar Award: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Tourette Syndrome

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• M. Zelime Elibol, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Neurology, Harvard Medical School

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 8, 2016
• Study Start: June 1, 2016
• Primary Completion: November 3, 2017
• Study Completion: November 3, 2017
• Last Updated: August 3, 2018

Record last verified: 2018-08