Clinical Trials Logo

Clinical Trial Summary

The investigators propose to synchronize automated measurements of behavior - head, body, and face dynamics, gaze, and vocal prosody - with simultaneous recordings of brain activity in clinically relevant contexts.


Clinical Trial Description

Baylor College of Medicine (BCM), University of Pittsburgh (UPitt) and Brown University will collaborate on this research project. BCM will be the only site that will enroll study subjects and perform study assessments. UPitt and Brown will supervise data management, measurement and modeling of multimodal signals and collaborate on research design and machine learning. Following initial screening, subjects will participate in one testing session lasting about 2 hours. The addition of these preliminary studies will allow investigators to obtain information in order to differentiate and code OCD-distress versus social anxiety and identify rituals related to OCD. Research Material, Data, and Information to be collected: Interviews, rating scales, video, audio, behavioral assessments, and heart rate will be obtained. Preliminary Testing in Un-implanted Subjects: Automated Behavioral Measures of OCD-related Distress (i.e., obsessions and urge to ritualize) and Overt Rituals: The Provocation OC task (Provoc) and the Trier Social Stress Test (TSST) will be used to evoke OC-related distress and anxiety unrelated to OCD (e.g., performance anxiety), respectively. These tasks will be preceded by a neutral baseline (the subject may be asked to describe how they traveled to the clinic to the experimenter) and a positive affect induction, the Broad-Minded Affective Coping procedure (BMAC) a clinical technique that uses recalled positive autobiographical memories and mental imagery to elicit positive affect. Because anxiety and negative affect may have carryover effects, neutral baseline and BMAC will be presented prior to the non-OCD and OCD distress inductions. In the BMAC, subjects will be instructed to recall and describe a recent positive memory/experience. The order of Provoc and TSST will be counterbalanced across the subjects. Use of a conveyor belt may be used during the Provoc tasks to present the evoking stimuli. Simultaneously recorded measures are noted in the Table attached in Section S and include: AFAR, new suite of behavioral measures (shown as shaded), hand/arm movements and heart rate. A third provocation task will be added to elicit overt rituals (e.g., handwashing) in the clinic. It will occur following the BMAC and TSST/Provoc tasks and a relaxation break. Subjects will be asked to wash their hands at a sink in our clinic inside an exam room where their behaviors will be recorded using hardware-synchronized cameras: one, to capture frontal view of the face for AFAR; and another, to record full body movement for CPM. The investigators are aware of only one prior study of automated coding of compulsive behavior. In that study, a computer vision approach was able to discriminate subjects with OCD from healthy subjects on the basis of handwashing videos in which regions of interest (ROIs) were defined for objects (e.g., soap dispenser) used for handwashing. The investigators will combine this ROI paradigm with a CPM approach that captures hand and body movements. Dropouts from the ritual paradigm will be replaced. These same tasks will also be performed on up to 4 subjects that have consented to receive a DBS implant on a separate protocol. Informed consent will also be collected from these implanted subjects for the purpose of completing the tasks described above on this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03459456
Study type Observational
Source Baylor College of Medicine
Contact Carmen Vasquez
Phone 713-798-4729
Email anav@bcm.edu
Status Recruiting
Phase
Start date June 11, 2018
Completion date June 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04934007 - Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder N/A
Recruiting NCT04071990 - Family Involvement in CBGT of OCD: a Randomized Controlled Trial N/A
Completed NCT02541968 - Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Recruiting NCT05391503 - Light Therapy for Obsessive-compulsive Disorder (OCD) N/A
Recruiting NCT04539951 - Pragmatic Trial of Obsessive-compulsive Disorder Phase 2
Completed NCT03416504 - Methods for Managing Intrusive Thoughts N/A
Not yet recruiting NCT06029738 - Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD N/A
Recruiting NCT02844049 - European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS N/A
Terminated NCT02909660 - What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder N/A
Completed NCT02911324 - Cannabinoid Medication for Adults With OCD Phase 1/Phase 2
Completed NCT02217995 - Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients N/A
Terminated NCT02234011 - A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder Phase 2
Withdrawn NCT01953042 - Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders N/A
Completed NCT02655926 - Deep Brain Stimulation for Severe Obsessive Compulsive Disorder N/A
Completed NCT04919785 - Deep Brain Stimulation in Severe Obsessive-compulsive Disorder N/A
Terminated NCT00758966 - Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder Phase 2
Completed NCT00742664 - Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project Phase 1/Phase 2
Completed NCT00523718 - Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder Phase 2
Completed NCT00074815 - Treatment of Obsessive Compulsive Disorder in Children Phase 3