Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 3 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | December 2014 |
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.
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).
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).
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
We found this trial at
1
site
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
