Cognitive Training for Fragile X Syndrome

Fragile X Syndrome Clinical Trial

Official title:

Cognitive Training for Fragile X Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747394
• Other study ID #: 428005
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 18, 2018

Study information

• Verified date: May 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fragile X Syndrome
• Syndrome

Intervention

Other:
• Working Memory Training

Locations

Country	Name	City	State
United States	M.I.N.D. Institute, U.C. Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory	Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory	5-6 weeks
Secondary	Wechsler Intelligence Scale for Children-IV Digit Span		5-6 weeks
Secondary	Wechsler Intelligence Scale for Children-IV Digit Span		3 month followup
Secondary	Kiddie Test of Attentional Performance (KiTAP)		5-6 weeks
Secondary	Kiddie Test of Attentional Performance (KiTAP)		3 month followup
Secondary	Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)		5-6 weeks
Secondary	Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)		3 month followup
Secondary	Swanson, Nolan and Pelham (SNAP-IV)		5-6 weeks
Secondary	Swanson, Nolan and Pelham (SNAP-IV)		3 month followup