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

Intellectual Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616796
• Other study ID #: 31648
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2015
• Est. completion date: December 2020

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fragile X Syndrome
• Intellectual Disability
• Syndrome

Intervention

Behavioral:
• Social gaze training
Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of social gaze aversion recorded during the social challenge		3 days
Primary	Heart rate recorded during the social challenge		3 days
Primary	Total t-score on the Social Responsiveness Scale (SRS)		4 weeks
Secondary	Verbal responses and pauses in conversation observed during the social challenge		3 days
Secondary	Fractional Amplitude of Low Frequency fluctuations (fALLF) measured in the insular cortex		3 days