CClinicalTrials.gg
CompletedNCT02747394Updated May 3, 2019

Cognitive Training for Fragile X Syndrome

An interventional study of Working Memory Training in Fragile X Syndrome, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-05-03.

Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jan 2013, registered Apr 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fragile X Syndrome
03

In context

Fragile X Syndrome

110 studies on the registry are indexed under Fragile X Syndrome; 23 are open to participants now.

This study's enrollment of 106 is above the median of 58 across 88 interventional studies indexed under Fragile X Syndrome.

Browse Fragile X Syndrome studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • previous Cogmed training
  • significant medical problems that would interfere with the study or significant brain trauma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Adaptive Cogmed

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

    Other: Working Memory Training

  • Other
    Non-Adaptive Cogmed

    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

  • OtherWorking Memory Training

    Also known as: Cogmed

06

What researchers measure

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

    Time frame: 5-6 weeks

Secondary outcomes

  1. Wechsler Intelligence Scale for Children-IV Digit Span

    Time frame: 5-6 weeks

  2. Wechsler Intelligence Scale for Children-IV Digit Span

    Time frame: 3 month followup

  3. Kiddie Test of Attentional Performance (KiTAP)

    Time frame: 5-6 weeks

  4. Kiddie Test of Attentional Performance (KiTAP)

    Time frame: 3 month followup

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

    Time frame: 5-6 weeks

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

    Time frame: 3 month followup

  7. Swanson, Nolan and Pelham (SNAP-IV)

    Time frame: 5-6 weeks

  8. Swanson, Nolan and Pelham (SNAP-IV)

    Time frame: 3 month followup

07

Study locations

1 site
  • M.I.N.D. Institute, U.C. Davis
    Sacramento, California 95817, United States
08

References and documents

Publications

  • 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. PubMed 30982467 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02747394
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Apr 21, 2016
Start date
Jan 2013
Primary completion
Oct 18, 2018
Completion
Oct 18, 2018
Last update
May 3, 2019

Study contacts

David Hessl
principal investigator · UC Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion