Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment

Completed

• Conditions: Fragile X Syndrome; Autism Spectrum Disorders; Psychosis

• Registration Number: NCT01364818
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of the proposed research is to study the potential changes in biomarkers of patients with neurodevelopmental disorders in response to treatment in clinical trials or in private psychiatry practice utilizing non-invasive psychophysiological measurements. The investigators plan to obtain psychophysical measurements throughout several periods of treatment.

Detailed Description

This study will employ a non-invasive custom-built four-point vertical displacement stimulator. This is used to deliver sinusoidal vibrations at very low amplitudes (0-400 microns) to the tips of the fingers. The forearm of the subject rests on the stimulator, the finger tips are vibrated, and the subject answers questions prompted by a computer monitor about their perception of the stimuli. Research staff may explain questions and prompts in a way that may be better understood by the subjects if the subjects experience any difficulty.

This device will be used to obtain objective psychophysical measurements as subjects undergo treatment. The investigators hope that this study will eventually assist in the long term goal of studying ways to develop diagnostic methods, based on changes in cortical information processing capabilities that occur with neurodevelopmental disorders. This would enable clinicians to more objectively determine prognosis and the best course of intervention for their patients.

This study will consent up to 60 subjects who are have initiated or changed pharmacologic treatment as either a participant in a clinical trial or as a private patient of one of the study doctors. Subjects who are a participant in another clinical trial may be one an active medication or a non-active medication(placebo). Subjects will have 7 visits in this study (w0 prior to initiating new treatment, and 4,8, 26 52,78 and 104 weeks after starting the the new treatment. The latter visits may occur either while the individual is taking the medication or after the individual has stopped treatment (in order to assess persistence of treatment-related changes).

Study Timeline

• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-02
• Study Start: 2011-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Subjects who are eligible to participate in a clinical trial conducted by Dr. Sikich or individuals who have initiated/changed pharmacologic treatment (as private patient of a study physician)
• Diagnosis of autism spectrum disorder (ASD), psychotic spectrum disorder (PSD), or Fragile X syndrome.
• Ages 3-45 inclusive

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Exclusion Criteria

• Non-English Speaking subject or parent/guardian

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-Post Treatment Differences between Groups	Subjects' V1 occurs within 2 wks of start of tx, V2 within 2 wks of tx midpt, V3 within 1 wk of end of tx. V4 will occur at Mo. 6, V5 will occur at Mo. 12, V6 will occur at Mo. 18, V7 will occur at Mo. 24/End of Study.	The primary analyses will examine whether the pre-post treatment difference in the effect of confounding stimuli (eg. ratio of confounded stimuli/control stimuli) on amplitude discrimination varies between the two groups (active treatment, no active treatment group) using an unpaired t test.

Trial Locations

Locations (1)

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States