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

Computerized Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder and Comorbid Tourette Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome; Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Targeted Cognitive Training (TCT); Other: Youth Appropriate Online Games

Detailed Description

Because impairments in executive functions (EFs), such as working memory, are associated with functional impairments in youth with neurodevelopmental and neuropsychiatric disorders, strategies that target EFs are critical. Neuroplasticity-based cognitive training has been found to improve cognition in youth with ADHD and in adults with schizophrenia. In this trial, the investigators seek to extend the relevance of computerized cognitive training to youth with comorbid ADHD and Tourette Syndrome. Given the literature, the investigators hypothesize that computerized working memory training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with ADHD+TS. The investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity-based cognitive training or enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be assessed again after 30 training sessions over 6 weeks and then again at a one-month follow-up.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The investigators will limit inclusion to youth between the ages of 7-13 who carry current diagnoses of ADHD+TS and who have a treating physician at a Partners affiliated hospital or clinic.
2. The investigators will include youth who have undergone neuropsychological testing in the prior 3 years.

Exclusion Criteria:

1. The investigators will exclude patients with intellectual disability in order to more directly extend the prior literature to the ADHD+TS population.
2. 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).
3. 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).
4. 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.
5. 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.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cognitive Training; Targeted Cognitive Training (TCT)	Behavioral: Targeted Cognitive Training (TCT); 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.
PLACEBO_COMPARATOR: Youth Appropriate Online Games; Engaging games not designed to improve cognition	Other: Youth Appropriate Online Games; Engaging games not designed to improve cognition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Louis V. Gerstner III Research Scholar Award
• Investigators: Principal Investigator: M. Zelime Elibol, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): November 3, 2017
• Study Completion (ACTUAL): November 3, 2017

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (ESTIMATE): April 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Attention-Deficit/Hyperactivity Disorder; Tourette Syndrome; Working Memory Training
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Tourette Syndrome
• Other Study ID Numbers: 2015P002512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED