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OpenTrials
Completed

NCT Number: NCT02747394

Cognitive Training for Fragile X Syndrome

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Working Memory Training

Other

Other names: Cogmed

Primary outcomes

  1. 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

  1. Wechsler Intelligence Scale for Children-IV Digit Span

    Time frame: 5-6 weeks

  2. Wechsler Intelligence Scale for Children-IV Digit Span

    Time frame: 3 month followup

  3. Kiddie Test of Attentional Performance (KiTAP)

    Time frame: 5-6 weeks

  4. Kiddie Test of Attentional Performance (KiTAP)

    Time frame: 3 month followup

  5. Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)

    Time frame: 5-6 weeks

  6. Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)

    Time frame: 3 month followup

  7. Swanson, Nolan and Pelham (SNAP-IV)

    Time frame: 5-6 weeks

  8. Swanson, Nolan and Pelham (SNAP-IV)

    Time frame: 3 month followup

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2016
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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