Cognitive Training for Fragile X Syndrome
Primary Purpose
Fragile X Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Working Memory Training
Sponsored by
About this trial
This is an interventional treatment trial for Fragile X Syndrome
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
Sites / Locations
- M.I.N.D. Institute, U.C. Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Adaptive Cogmed
Non-Adaptive Cogmed
Arm Description
5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed
5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Wechsler Intelligence Scale for Children-IV Digit Span
Wechsler Intelligence Scale for Children-IV Digit Span
Kiddie Test of Attentional Performance (KiTAP)
Kiddie Test of Attentional Performance (KiTAP)
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Swanson, Nolan and Pelham (SNAP-IV)
Swanson, Nolan and Pelham (SNAP-IV)
Full Information
NCT ID
NCT02747394
First Posted
April 5, 2016
Last Updated
May 1, 2019
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT02747394
Brief Title
Cognitive Training for Fragile X Syndrome
Official Title
Cognitive Training for Fragile X Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fragile X Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive Cogmed
Arm Type
Experimental
Arm Description
5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed
Arm Title
Non-Adaptive Cogmed
Arm Type
Other
Arm Description
5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed
Intervention Type
Other
Intervention Name(s)
Working Memory Training
Other Intervention Name(s)
Cogmed
Primary Outcome Measure Information:
Title
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory
Description
Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory
Time Frame
5-6 weeks
Secondary Outcome Measure Information:
Title
Wechsler Intelligence Scale for Children-IV Digit Span
Time Frame
5-6 weeks
Title
Wechsler Intelligence Scale for Children-IV Digit Span
Time Frame
3 month followup
Title
Kiddie Test of Attentional Performance (KiTAP)
Time Frame
5-6 weeks
Title
Kiddie Test of Attentional Performance (KiTAP)
Time Frame
3 month followup
Title
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Time Frame
5-6 weeks
Title
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Time Frame
3 month followup
Title
Swanson, Nolan and Pelham (SNAP-IV)
Time Frame
5-6 weeks
Title
Swanson, Nolan and Pelham (SNAP-IV)
Time Frame
3 month followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hessl
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
M.I.N.D. Institute, U.C. Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30982467
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.
Results Reference
derived
Learn more about this trial
Cognitive Training for Fragile X Syndrome
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