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Trial record 45 of 74 for:    "fragile x syndrome"

Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome

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ClinicalTrials.gov Identifier: NCT02616796
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Scott Hall, Stanford University

Brief Summary:
The purpose of the study is to evaluate a 2-3 day treatment probe targeted to improving social gaze behavior in children with fragile X syndrome (FXS). The investigators will use the principles of Applied Behavior Analysis (ABA) to shape appropriate social skills. Importantly, the investigators propose to examine the effects of this treatment probe on brain and behavior.

Condition or disease Intervention/treatment Phase
Fragile X Syndrome Intellectual Disability Behavioral: Social gaze training Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Social Gaze Training on Brain and Behavior in Fragile X Syndrome
Study Start Date : April 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Social gaze training
Appropriate social gaze behavior will be reinforced using the principles of Applied Behavior Analysis.
Behavioral: Social gaze training
Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.

No Intervention: No Training
Appropriate social gaze behavior will not be reinforced.



Primary Outcome Measures :
  1. Percentage of social gaze aversion recorded during the social challenge [ Time Frame: 3 days ]
  2. Heart rate recorded during the social challenge [ Time Frame: 3 days ]
  3. Total t-score on the Social Responsiveness Scale (SRS) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Verbal responses and pauses in conversation observed during the social challenge [ Time Frame: 3 days ]
  2. Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex [ Time Frame: 3 days ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Boys diagnosed with fragile X syndrome
  2. Boys with intellectual disability who do not have FXS or other known genetic disorder associated with intellectual disability
  3. Age 8 to 18 years inclusive
  4. Ability to travel to Stanford
  5. Vineland Adaptive Behavior Scales standard score between 50 and 75 points

Exclusion Criteria:

  1. Sensory impairments, or any other serious medical or neurological condition that affects growth or development (e.g., seizure disorder, diabetes, congenital heart disease).
  2. Materials in body that would preclude an MRI scan (e.g., dental braces).

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): NCT02616796


Contacts
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Contact: Scott S Hall, PhD 650-498-4799 hallss@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Scott S Hall, PhD    650-498-4799    hallss@stanford.edu   
Principal Investigator: Scott S Hall, PhD         
Sponsors and Collaborators
Stanford University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott Hall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02616796     History of Changes
Other Study ID Numbers: 31648
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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