NCT02747394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2018

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

5.8 years

First QC Date

April 5, 2016

Last Update Submit

May 1, 2019

Conditions

Fragile X Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Wechsler Intelligence Scale for Children-IV Digit Span

    5-6 weeks

  • Wechsler Intelligence Scale for Children-IV Digit Span

    3 month followup

  • Kiddie Test of Attentional Performance (KiTAP)

    5-6 weeks

  • Kiddie Test of Attentional Performance (KiTAP)

    3 month followup

  • Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)

    5-6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Adaptive Cogmed

EXPERIMENTAL

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

Other: Working Memory Training

Non-Adaptive Cogmed

OTHER

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

Other: Working Memory Training

Interventions

Working Memory TrainingOTHER
Also known as: Cogmed
Adaptive CogmedNon-Adaptive Cogmed

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • previous Cogmed training
  • significant medical problems that would interfere with the study or significant brain trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.I.N.D. Institute, U.C. Davis

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

    PMID: 30982467DERIVED

MeSH Terms

Conditions

Fragile X Syndrome

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGenetic Diseases, X-LinkedHeredodegenerative Disorders, Nervous System

Study Officials

  • David Hessl

    UC Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 21, 2016

Study Start

January 1, 2013

Primary Completion

October 18, 2018

Study Completion

October 18, 2018

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

US(1)