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Clinical Trials/NCT04075890
NCT04075890CompletedNot Applicable

Arbitration Between Habitual and Goal-directed Behavior in Obsessive-compulsive Disorder: Circuit Dynamics and Effects of Noninvasive Neurostimulation

University of California, Los Angeles1 site in 1 country66 target enrollmentStarted: July 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
Strength of Behaving Model-based (Goal-directed)

Study Overview

Brief Summary

People utilize two behavioral strategies, goal-directed and habitual, when engaging in value-based decision-making that involves rewarding or punishing outcomes. Accumulating evidence suggests an imbalance between habitual and goal-directed behavior in favor of habitual control in parallel with exaggerated tendency toward compulsive/harm avoidance behavior in OCD. In healthy subjects, an arbitration mechanism has been proposed recently that controls the balance between those two strategies of action selection. Arbitration regions regulate the goal-directed/habitual decision-making balance by selectively downregulating the activity of the habitual regions. This project aims to explore the neurobehavioral characteristics of arbitration mechanism and its relationship with behaviors and clinical phenotypes in OCD by applying computational cognitive neuroscience, clinical task-based functional magnetic resonance imaging (fMRI) and transcranial direct current stimulation (tDCS) method.

Detailed Description

Investigators will recruit 30 male and female adults (age 18-65) with OCD and 30 age-, sex-, and education-matched healthy (medically, neurologically and psychiatrically) controls for this project. Each participant will come for three sessions. There will be 3-4 days interval between sessions:

Session 1 that includes initial clinical assessment and obtaining T1 structural image (needed for neuronavigation analysis and electric field modeling).

Session 2 and 3 that include performing two separate decision-making and symptom provocation-avoidance tasks by participants with OCD and healthy controls under two conditions: while scanned inside the MRI scanner (no tDCS) or while receiving neuronavigated tDCS neurostimulation outside the scanner (no fMRI imaging). As participates will perform each task twice, there might be an order effect on task performance. For minimizing the impact of such a potential order effect on imaging and tDCS results, participants will be randomly assigned to undergo scanning in the session 2 and then receive tDCS in the session 3 or in the opposite order (tDCS in session 2 and then imaging in session 3) but in each session only one of imaging or tDCS experiments (for both tasks) will be conducted for each participant. OCD-relevant and aversive picture rating (explained below) will be done always in the session 3 as the last experiment.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •A) OCD participants inclusion criteria:
  • •DSM-5 diagnostic criteria for OCD as primary (most severe) diagnosis (based on the Mini International Neuropsychiatric Interview).
  • •Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score is equal or greater than
  • •unmediated or being on a stable dose of medication (only SSRIs and clomipramine) for at least 12 weeks prior to the study.
  • •fluent English speaker.
  • •signed informed consent.
  • •B) OCD participants

Exclusion Criteria

  • •IQ greater than 80 on the Wechsler Abbreviated Scales of Intelligence.
  • •lifetime DSM-5 diagnosis of mania, psychotic disorder, or substance dependence (per MINI).
  • •current DSM-5 diagnosis of MDD if Montgomery-Asberg Depression Scale (MADRS) scores are equal or greater than 35 (severe), or ADHD.
  • •taking any psychotropic medication other than SSRIs or clomipramine.
  • •severe psychiatric symptom that requires immediate inpatient psychiatric intervention such as suicidality.
  • •presence of any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment.
  • •C) Healthy control inclusion criteria:
  • •1-males and females age 18-65 years with signed informed consent and IQ greater than 80 on WASI.
  • •D) Exclusion criteria for all participants:
  • •presence of any MR scan contraindications particularly body metal or positive pregnancy test.
  • •medical conditions in which cerebral metabolism might be compromised such as thyroid disorders, diabetes or current tobacco smoking (potential effect on imaging endpoints).
  • •any history of seizure disorders.

Arms & Interventions

Healthy subjects

Active Comparator

Intervention: transcranial Direct Current Stimulation (tDCS) (Device)

OCD subjects

Active Comparator

Intervention: transcranial Direct Current Stimulation (tDCS) (Device)

Outcomes

Primary Outcomes

Strength of Behaving Model-based (Goal-directed)

Time Frame: On the second or third session when subjects performed the task in the MRI scanner.

Strength of behaving model-based (goal-directed) is measured and quantifiedas a continuous real number between 0 and 1. Here, having a strength's valueof 1 of behaving model-based means that subject in her/his decision-making,exclusively and always utilizes a model-based (goal-directed) strategy fordecision making and having a value of Zero means not utilizing model-based(goal-directed) strategy at all when decising.

Reaction Time in Response to Stimuli With OCD Themes

Time Frame: On the second or third session when subjects performed the task in the MRI scanner.

This is a time interval (in seconds) between the start of presentation of visual stimuli with OCD themes and when subjects pushed a bottom to stop the presentation when they could not tolerate those more during symptom provocation and avoidance task.

Strength of Frontal Arbitration Modulation of Basal Ganglia Habit Region.

Time Frame: On the second or third session when subjects performed the task in the MRI scanner

Here, by applying Dynamic Causal Modeling (DCM) method, we measured thestrength of frontal arbitration (the interior frontal gyrus (IFG)) modulation ofbasal ganglia habit region (the posterolateral putamen) in terms of the effective(directed) connectivity between the interior frontal gyrus (IFG) andposterolateral putamen. This DCM-based effective connectivity can have avalue between -1 and +1. A value of -1 means a maximum effective connectivitybetween the interior frontal gyrus (IFG) and posterolateral putamen. A value of+1 means maximum excitatory effective connectivity between the interior frontalgyrus (IFG) and posterolateral putamen. And a value of 0 means no effectiveconnectivity between the interior frontal gyrus (IFG) and posterolateralputamen.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reza Tadayon-Nejad, MD, PhD

Assistant Clinical Professor of Psychiatry

University of California, Los Angeles

Study Sites (1)

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