Cognitive Training for Fragile X Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-10-18

Brief Summary

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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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Detailed Description

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Conditions

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Fragile X Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Adaptive Cogmed

5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed

Group Type EXPERIMENTAL

Working Memory Training

Intervention Type OTHER

Non-Adaptive Cogmed

5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed

Group Type OTHER

Working Memory Training

Intervention Type OTHER

Interventions

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Working Memory Training

Intervention Type OTHER

Other Intervention Names

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Cogmed

Eligibility Criteria

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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