Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
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Purpose
| Condition |
|---|
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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 |
- 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.
| Enrollment: | 25 |
| Study Start Date: | September 2011 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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.
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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.
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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 (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01364818
| United States, North Carolina | |
| University of North Carolina Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Linmarie Sikich, M.D. | University of North Carolina, Chapel Hill |
More Information
| 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: | April 14, 2016 |
| Health Authority: | United States: Institutional Review Board |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Mental Retardation, X-Linked Disease Autism Spectrum Disorder Fragile X Syndrome Neurodevelopmental Disorders Pathologic Processes Child Development Disorders, Pervasive Mental Disorders 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 |
ClinicalTrials.gov processed this record on September 30, 2016