Clinical trial NCT02747394: Cognitive Training for Fragile X Syndrome
Official title: Cognitive Training for Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragile X Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 106
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory
timeFrame: 5-6 weeks
Secondary outcomes:
measure: Wechsler Intelligence Scale for Children-IV Digit Span
timeFrame: 5-6 weeks
measure: Wechsler Intelligence Scale for Children-IV Digit Span
timeFrame: 3 month followup
measure: Kiddie Test of Attentional Performance (KiTAP)
timeFrame: 5-6 weeks
measure: Kiddie Test of Attentional Performance (KiTAP)
timeFrame: 3 month followup
measure: Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
timeFrame: 5-6 weeks
measure: Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
timeFrame: 3 month followup
measure: Swanson, Nolan and Pelham (SNAP-IV)
timeFrame: 5-6 weeks
measure: Swanson, Nolan and Pelham (SNAP-IV)
timeFrame: 3 month followup
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: M.I.N.D. Institute, U.C. Davis
state: California
Study officials:
affiliation: UC Davis
name: David Hessl
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hessl D, Schweitzer JB, Nguyen DV, McLennan YA, Johnston C, Shickman R, Chen Y. Cognitive training for children and adolescents with fragile X syndrome: a randomized controlled trial of Cogmed. J Neurodev Disord. 2019 Apr 15;11(1):4. doi: 10.1186/s11689-019-9264-2.