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

Primary Purpose

OCD, Decision-Making, tDCS

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for OCD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

A) OCD participants inclusion criteria:

  1. DSM-5 diagnostic criteria for OCD as primary (most severe) diagnosis (based on the Mini International Neuropsychiatric Interview).
  2. Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score is equal or greater than 16.
  3. unmediated or being on a stable dose of medication (only SSRIs and clomipramine) for at least 12 weeks prior to the study.
  4. fluent English speaker.
  5. signed informed consent.

B) OCD participants exclusion criteria:

  1. IQ greater than 80 on the Wechsler Abbreviated Scales of Intelligence.
  2. lifetime DSM-5 diagnosis of mania, psychotic disorder, or substance dependence (per MINI).
  3. current DSM-5 diagnosis of MDD if Montgomery-Asberg Depression Scale (MADRS) scores are equal or greater than 35 (severe), or ADHD.
  4. taking any psychotropic medication other than SSRIs or clomipramine.
  5. severe psychiatric symptom that requires immediate inpatient psychiatric intervention such as suicidality.
  6. 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:

  1. presence of any MR scan contraindications particularly body metal or positive pregnancy test.
  2. medical conditions in which cerebral metabolism might be compromised such as thyroid disorders, diabetes or current tobacco smoking (potential effect on imaging endpoints).
  3. any history of seizure disorders.

Sites / Locations

  • UCLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy subjects

OCD subjects

Arm Description

Outcomes

Primary Outcome Measures

Change in Action Selection Ratio
Participants perform a decision-making task in which goal-directed and habitual strategies of decision-making compete to govern the manner of action selection. Action Selection Ratio is the ratio of goal-directed/habitual action selection strategies during the task. Change in Action Selection Ratio will be measured across 3 sessions (baseline, during fMRI and finally tDCS sessions).
Activity Level of Arbitration Regions
Activity level of arbitration regions including the right and left inferior lateral prefrontal cortex and right frontopolar cortex in terms of regional BOLD signals during decision-making and symptom provocation-avoidance tasks.
Arbitration-Habitual Connectivity
The fMRI based functional connectivity between the arbitration regions(the right and left inferior lateral prefrontal cortex and right frontopolar cortex) and habitual regions (putamen, supplementary motor area) measured by psychophysiological interactions method during decision-making and symptom provocationavoidance tasks.
Change in Timing of Avoidance Behavior
During symptom provocation-avoidance task, OCD-relevant photos will be shown to participants and they will be instructed to push a button to stop the picture presentation when they feel distressed such that they desire to stop viewing the photo. Timing of Avoidance Behavior is the interval between starting time of photo presentation until pushing the stop button. Change in Timing of Avoidance Behavior will be measured across 3 sessions (baseline, during fMRI and finally tDCS sessions).

Secondary Outcome Measures

Full Information

First Posted
August 29, 2019
Last Updated
November 16, 2020
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04075890
Brief Title
Arbitration Between Habitual and Goal-directed Behavior in Obsessive-compulsive Disorder: Circuit Dynamics and Effects of Noninvasive Neurostimulation
Official Title
Arbitration Between Habitual and Goal-directed Behavior in Obsessive-compulsive Disorder: Circuit Dynamics and Effects of Noninvasive Neurostimulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OCD, Decision-Making, tDCS, fMRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Title
OCD subjects
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
tDCS is a non-invasive brain stimulation method by which constant low direct current can be delivered to the sculpt for changing the excitability of neuronal structure adjunct to the stimulating electrode.
Primary Outcome Measure Information:
Title
Change in Action Selection Ratio
Description
Participants perform a decision-making task in which goal-directed and habitual strategies of decision-making compete to govern the manner of action selection. Action Selection Ratio is the ratio of goal-directed/habitual action selection strategies during the task. Change in Action Selection Ratio will be measured across 3 sessions (baseline, during fMRI and finally tDCS sessions).
Time Frame
At baseline AND twice in two separate sessions with 3-4 days interval.
Title
Activity Level of Arbitration Regions
Description
Activity level of arbitration regions including the right and left inferior lateral prefrontal cortex and right frontopolar cortex in terms of regional BOLD signals during decision-making and symptom provocation-avoidance tasks.
Time Frame
baseline
Title
Arbitration-Habitual Connectivity
Description
The fMRI based functional connectivity between the arbitration regions(the right and left inferior lateral prefrontal cortex and right frontopolar cortex) and habitual regions (putamen, supplementary motor area) measured by psychophysiological interactions method during decision-making and symptom provocationavoidance tasks.
Time Frame
baseline
Title
Change in Timing of Avoidance Behavior
Description
During symptom provocation-avoidance task, OCD-relevant photos will be shown to participants and they will be instructed to push a button to stop the picture presentation when they feel distressed such that they desire to stop viewing the photo. Timing of Avoidance Behavior is the interval between starting time of photo presentation until pushing the stop button. Change in Timing of Avoidance Behavior will be measured across 3 sessions (baseline, during fMRI and finally tDCS sessions).
Time Frame
At baseline but twice in two separate sessions with 3-4 days interval.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 16. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Tadayon-Nejad, MD, PhD
Phone
3102066389
Email
rtadayonnejad@mednet.ucla.edu
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Tadayon-Nejad, MD, PhD
Email
rtadayonnejad@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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