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Trial record 5 of 74 for:    "fragile x syndrome"

Cognitive Training for Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT02747394
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Fragile X Syndrome Other: Working Memory Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Training for Fragile X Syndrome
Actual Study Start Date : January 2013
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : October 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Cogmed

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
Other Name: Cogmed




Primary Outcome Measures :
  1. Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory [ Time Frame: 5-6 weeks ]
    Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747394


Locations
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United States, California
M.I.N.D. Institute, U.C. Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: David Hessl UC Davis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02747394     History of Changes
Other Study ID Numbers: 428005
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Fragile X Syndrome
Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System