Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03459456 |
Other study ID # |
H41632 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 11, 2018 |
Est. completion date |
June 2024 |
Study information
Verified date |
June 2023 |
Source |
Baylor College of Medicine |
Contact |
Carmen Vasquez |
Phone |
713-798-4729 |
Email |
anav[@]bcm.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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.