Innovations In Clinical Neuroscience

CNS Summit 2016

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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[ V O L U M E 1 4 , N U M B E R 1 – 2 , J A N U A R Y – F E B R U A R Y 2 0 1 7 , S U P P L E M E N T ] Innovations in CLINICAL NEUROSCIENCE S7 Disclosures/funding: We are now working with several pharmaceutical companies. At this time, we are unable t o disclose all our current relationships. Sleep staging based on a reduced montage using two EOG channels Presenters: Dorffner G A ffiliations: The Siesta Group, Wien, Austria; Medical University of Vienna, Section for Artificial Intelligence and Decision Support, Vienna, Austria Objective: Currently, objective assessment of sleep architecture and sleep continuity in clinical trials relies on the recording of distinct biological signals (e.g., electroencephalography [EEG], electrooculography [EOG], and electromyography [EMG]) for a full night. This method—polysomnography (PSG)— is usually performed at specialized sleep labs requiring skilled personnel and full equipment, which, being expensive and to some extent burdensome for the patient, limits the number measurements to only a few nights in a protocol. This might not be representative for a patient's sleep. Thus, a portable, less intrusive, and self-applicable solution for sleep measurement would allow for the acquisition of more nights in the patient's familiar environment. The aim of this study was to investigate if a reduced setting requiring two EOG channels only would yield comparable results to a full PSG that includes six EEGs, two EOGs, and one EMG channel. Design: Sleep recordings from 36 healthy controls (2 nights each) were analyzed using a validated computer- assisted scoring system. Only the standard two EOG channels were used as input data, which were submitted to a modified version of the analyzer. Results: The main three states wakefulness (r=0.87), non-rapid eye movement (NREM) sleep (r=0.77), and rapid eye movement (REM) sleep (r=0.68), were identified effectively (full montage vs. reduced montage). On an epoch-by-epoch basis, Cohens Kappa was 0.65 ("good agreement") with agreement rates of 86 percent for waking (W), 81 percent for slow wave sleep (SWS), and 84 percent for REM. Conclusion: This work provides promising evidence that, with the proper modification of existing computer-based sleep scoring solutions, a reduced montage permits sleep measurements that lead to results comparable to full PSG, at l east with respect to many important sleep variables. Disclosures/funding: Georg Dorffner is employee and shareholder of The Siesta Group, Wein, Austria. COMPUTER-BASED TOOLS An electronic (eCOA)-prompted Yale Global Tic Severity Scale (YGTSS) with blinded internal scoring Presenters: Busner J 1 , Farber R 2 , O'Brien C 2 , Liang G 2 , Scahill L 3 , Coffey B 4 Affiliations: 1 Penn State College of Medicine, Department of Psychiatry, Hershey, Pennsylvania, and Bracket Global, Wayne, Pennsylvania; 2 Neurocrine Biosciences, Inc., San Diego, California; 3 Emory University, Atlanta, Georgia; 4 Icahn School of Medicine at Mount Sinai School, New York, New York Objective: The YGTSS is a gold- standard tic severity assessment in Tourette's syndrome (TS) studies. To improve ratings quality, we developed an eCOA-prompted YGTSS that provided rating guidance, captured rater scores, and generated rater-blinded algorithm-derived scores as quality checks. Design: An eCOA-prompted YGTSS was developed with TS experts. The eCOA YGTSS ensured correct navigation through the scale and assisted raters by displaying earlier endorsed tics, when needed, for motor and phonic severity ratings. The scale included algorithms for a second set of rater-blinded "tandem" scores. The scale is being piloted in two ongoing, placebo-controlled, multisite TS trials, one pediatric and one adult, with rater scores serving as efficacy data. Results: There were 99 visits by 20 raters that were completed at the time of the analysis. Correlations between rater and computer scores were high for each of the 10 YGTSS severity scores (range: 0.74–0.91, all p values <0.0001); for the Total Tic Score (TTS) (primary efficacy measure), the correlation was 0.95 (p<0.0001). The mean rater versus computer TTS scores were almost identical (28.8 and 28.5, respectively, NS). The findings did not differ between pediatric and adult subjects. Conclusion: Our internal scoring algorithms correlated significantly with all rater-selected motor, phonic, and TTS s cores, with the latter nearly identical. The work provides preliminary validation of our algorithms and supports the feasibility of the approach. In a risk-based monitoring model, less trained raters whose scores d eviate significantly from those of the internal algorithm might be selected for additional scrutiny and intervention. Disclosures/funding: Dr. Busner is an employee of Bracket Global, Wayne, Pennsylvania. Drs. Farber, O'Brien, and Liang are employees of Neurocrine Biosciences, Inc., San Diego, California. Dr. Scahill is a consultant to Roche, Bracket, Neuren Pharmaceuticals, MedAdvante, Coronado Biosciences, Inc., and Supernus Pharmaceuticals, Inc.; has received research support from the United States National Institute of Mental Health (NIMH) and Department of Defense; and has received royalties from Oxford and Guilford. Dr. Coffey has received honoraria from American Academy of Child and Adolescent Psychiatry; has received research support from Neurocrine, NIMH, Shire, and Catalyst Pharmaceuticals Inc.; serves on the advisory board, received Center of Excellence Funding, and is on the speakers bureau of Tourette Association of America; serves on the advisory board and receives research support from Auspex Pharmaceuticals; and serves on the advisory board of Genco Sciences. The electronic self-report of the C-SSRS (eC-SSRS) places little burden on patients initially and even less with repeated administrations Presenters: Yamamoto R 1 , Durand E 1 , Lima V 1 , Christopher D 1 , Yershova K 2 , Dallabrida S 1 Affiliations: 1 ERT Corp., New York, New York 2 ; Columbia University/New York State Psychiatric Institute, New York, New York Objective: A key factor to consider for instruments that measure suicidal ideation and behavior (SIB) is the duration of patient completion time. The Columbia Suicide Severity Rating Scale (C-SSRS) (interviewer completed) and electronic C- SSRS (eC-SSRS) (self-report) are sourced by the United States Food and Drug Administration (FDA) in the SIB Industry Guidance as recommended assessments.

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