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Clinical Translational Core




The Clinical Translational Core includes services to maximize participation of research subjects in IDDRC projects (the Participant Registries), services to support development of image processing tools, multi-modal brain imaging, EEG/ERP and eye tracking (the Brain-Behavior Measurement Laboratories), and consultation on design of behavioral studies, including technical assistance to train research assistants on test administration and assistance building clinical assessment teams (Behavior Navigator). The Core can provide expertise and resources for clinically-relevant insights into (1) early risk markers; (2) brain targets for therapeutics; (3) neural metrics characterizing the impact of intervention; and (4) brain mechanisms, leading to targeted approaches to intervention. The goals of the Core include recruitment and optimized utilization of research subjects for IDDRC clinical studies, and the provision of cutting-edge tools, services, resources, expert consultation and training in multi-modal brain measurement, including MRI/DTI/fMRI brain imaging, EEG/ERP, fNIRs and eye-tracking.

Research Participant Registries
The Registries facilitate the recruitment of subjects (individuals with developmental disorders and typically-developing subjects) for clinical studies led by IDDRC investigators. Registry staff contact and recruit research participants for 4 different databases: The Autism Registry, the Fragile X Registry, the Child Development Registry, and the General IDD Registry. Each registry includes information on individual demographics, medical history (including genetic syndrome and psychiatric history), and clinic-administered measures, such as IQ, adaptive behavior, and diagnostic instruments, to be used for identifying appropriate subjects for recruitment to particular studies. Each database also contains details necessary to identify subjects appropriate to studies with differing inclusion criteria. For example, studies on ASD may enroll participants based on IQ, family history (of ASD), history of ADOS administration, age and seizure history. In addition, because of difficulty identifying subjects with rare genetic syndromes, the Registries have established collaborative efforts with other research institutions to broaden recruitment success for IDDRC investigators.

Brain and Behavior Measurement Laboratories
The Brain-Behavior Measurement Laboratories provide critical support, including specialized infant/toddler EEG/ERP, fNIRs, and eye tracking approaches, and expert consultation for MRI/DTI/fMRI methods, for studies measuring brain and brain-related characteristics. Martin Styner, Associate Director of this Lab, has made new processing and analysis tools, such as novel software developed for processing brain images from infants, available to numerous studies of developing human and non-human primate brain, throughout the country. The Brain-Behavior Measurement Laboratories been instrumental for studies of early biomarkers (MRI, DTI, eye tracking, EEG) that could serve as predictors for later brain and behavioral abnormalities, as well as providing potential neurological indicators for tracking disorder outcomes. The core provides access to and training on well-established and validated neuroimaging methods and develops new methods and modifications of existing state-of-the-art image acquisition and analysis methods, including:

  • experimental protocol development
  • imaging data acquisition
  • storing and archiving of clinical study image data
  • maintenance of imaging databases
  • assistance and training with imaging data processing
  • development of novel imaging data analysis tools
  • quality assurance of image acquisition protocols
  • data transfer of image data to the image analysis lab
  • two- and three-dimensional segmentation to obtain quantitative measurements
  • rigorous validation and quality control of processing with intra- and inter-rater studies.

The Brain-Behavior Measurement Laboratories also includes The Developmental Electrophysiology Lab that provides assistance with study design, access to state-of-the-art EEG and fNIRS equipment, implementation of experimental protocols and support during EEG or fNIRS acquisition, design and programming of analysis pipelines for event-related potential spectral and time-frequency domain analysis, and assistance with handling, desensitizing, and managing infants and young children during data acquisition. The Core supports two EEG facilities, one on UNC campus, next to the Core imaging facilities and trainee offices, and a second system at an off-campus site, contiguous with the CIDD observation/clinical research rooms, with easy subject access and parking availability. These EEG facilities offer (1) two Electrical Geodesic Dense Array EEG Net Amplifier 300, for high-density EEG measurement, suitable for the infant/pediatric population; (2) a 64- channel NeuroScan SynAmps RT Amplifier with an active license for SCAN 4 Software for Neuroscan, (3) a 32-channel Synamps II Neuroscan system, and (4) a 64- channel Biosemi system, (5) a mobile 32-channel gTec Nautilus system, and (6) a mobile fNIRS devices model100. The Brain-Behavior Measurement Laboratories also provides assistant with Eye-tracking Studies: The Core offers IDDRC investigators access to sophisticated eye-tracking equipment, which provides a non-invasive method for exploring the behavioral correlates of brain function and maturation. An increasing number of ongoing studies are also integrating eye-tracking with functional imaging at the MRI scanners, both to control for eye-movement and fixation, as well as to explore the behavioral correlates of neural impairments in attention deployment in autism and schizophrenia. The Core includes two TOBII eye tracker systems (120Hz and a 60Hz) that can be used in studies with subjects across the age span, from infancy to adulthood.

Behavior Navigator
Finally, the Clinical Translational Core supports a Behavior Navigator to assist IDDRC researchers to conduct clinical studies. Heather Hazlett, Ph.D., Assistant Professor of Psychiatry and an experienced clinical neuropsychologist with IDD expertise, serves as the UNC IDDRC Behavioral Navigator. Her role as IDDRC Behavioral Navigator is to assist IDDRC researchers with the design and measurement of clinical intellectual and developmental disabilities (IDDs) studies as well as assistance with the development of clinical teams (for those investigators with limited clinical background). She can advise IDDRC researchers, and in particular those without extensive experience conducting clinical research, on the design of their studies, selection and interpretation of diagnostic, symptom, and neuropsychological measures, as well as practical aspects of their research (e.g., hiring experts and staff to conduct data collection for investigators who are not themselves experts in behavioral measurement). For more information or to inquire about accessing our Behavior Navigator services, contact Dr. Heather Cody Hazlett at heather_cody@med.unc.edu.

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