Cognitive Training for Fragile X Syndrome

University of California (UC) Davis

Status: Completed

Conditions: Fragile X Syndrome

Treatments: Other: Working Memory Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02747394

428005

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Adaptive Cogmed

Experimental group

Description:

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

Treatment:

Other: Working Memory Training

Non-Adaptive Cogmed

Other group

Description:

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

Treatment:

Other: Working Memory Training