Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01364818
First received: May 16, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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
Autism Spectrum Disorders
Psychosis
Fragile X Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of Potential Biomarkers to Assess Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Pre-Post Treatment Differences between Groups [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Placebo Comparator: Placebo
Active Comparator: Active Medication

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).

  Eligibility

Ages Eligible for Study:   3 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants recruited for a clinical trial conducted by Dr. Sikich, or are private patients of one of the study doctors.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364818

Locations
United States, North Carolina
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
  More Information

No publications provided

Responsible Party: Linmarie Sikich, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01364818     History of Changes
Other Study ID Numbers: 11-0962
Study First Received: May 16, 2011
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Fragile X Syndrome
Mental Disorders
Psychotic Disorders
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 20, 2014