Cognitive Training for Fragile X Syndrome

Not Applicable

Completed

• Conditions: Fragile X Syndrome
• Interventions: Other: Working Memory Training

• Registration Number: NCT02747394
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2018-10-18
• Study Completion: 2018-10-18
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adaptive Cogmed	Working Memory Training	5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed
Non-Adaptive Cogmed	Working Memory Training	5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed

Primary Outcome Measures

Name	Time	Method
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory	5-6 weeks	Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M.I.N.D. Institute, U.C. Davis; 🇺🇸 Sacramento, California, United States