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Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT01364818
Collaborator
(none)
25
Enrollment
1
Location
39
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Characterization of Potential Biomarkers to Assess Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Placebo Comparator: Placebo

    No treatment/ performance of somatosensory task (cortical metrics) without any intervention. The somatosory task will be performed before any intervention/at the midpoint/ and finally at the end.
    Active Comparator: Active Medication

    Treatment (memantine, lurasidone)/ performance of somatosensory task (cortical metrics) with intervention. The somatosory task will be performed before any intervention has started/at the midpoint/ and finally at the end.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Exclusion Criteria:

    • Non-English Speaking subject or parent/guardian

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina Chapel Hill Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Linmarie Sikich, M.D., University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Linmarie Sikich, MD, Associate Professor, University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT01364818
    Other Study ID Numbers:
    • 11-0962
    First Posted:
    Jun 2, 2011
    Last Update Posted:
    Apr 18, 2016
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Fragile X Syndrome
    Autism Spectrum Disorder
    Neurodevelopmental Disorders

    Study Results

    No Results Posted as of Apr 18, 2016