Psychosis Clinical Trial
Official title:
Characterization of Potential Biomarkers to Assess Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
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.
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).
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Observational Model: Case Control, Time Perspective: Prospective
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