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Completed

NCT Number: NCT02616796

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

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.

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Key information

Conditions

Fragile X Syndrome Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sex Chromosome Disorders Signs and Symptoms X-Linked Intellectual Disability

Age range

8 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Social gaze training

Behavioral

Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2015
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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