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Clinical Trials/NCT02747394
NCT02747394
Completed
Not Applicable

Cognitive Training for Fragile X Syndrome

University of California, Davis1 site in 1 country106 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fragile X Syndrome
Sponsor
University of California, Davis
Enrollment
106
Locations
1
Primary Endpoint
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and behavioral deficits. This translational work has led to multiple national and international controlled trials in humans with FXS now underway. However, in contrast to the heavy focus on medication treatments, there have been no controlled trials to empirically-validate cognitive or behavioral interventions for FXS. The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the efficacy of Cogmed, a cognitive training program proven to enhance working memory and executive/frontal function in a variety of clinical populations. Demonstration of effective Cogmed training for FXS would represent a major advance in the field, one that may also generalize to other forms of intellectual disability. Furthermore, it is critical to determine whether the targeted pharmacological treatments can accelerate learning and cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for testing hypotheses focused on combined efficacy of medication and cognitive training.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
October 18, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • fragile X full mutation
  • normal or corrected vision
  • English or Spanish speaking
  • ability to pass three-span items following completion of a Cogmed training session at baseline
  • parental agreement to maintain adherence to the training schedule and to not alter other treatments during the study unless medically necessary

Exclusion Criteria

  • previous Cogmed training
  • significant medical problems that would interfere with the study or significant brain trauma

Outcomes

Primary Outcomes

Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory

Time Frame: 5-6 weeks

Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory

Secondary Outcomes

  • Wechsler Intelligence Scale for Children-IV Digit Span(3 month followup)
  • Kiddie Test of Attentional Performance (KiTAP)(3 month followup)
  • Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)(3 month followup)
  • Swanson, Nolan and Pelham (SNAP-IV)(3 month followup)

Study Sites (1)

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