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

NCT04075890 | Completed Results FDA Device

• 1 other identifier: 17-001360
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Decision-Making; tDCS; fMRI; OCD

Outcome Measures

Primary Outcomes (3)

• Strength of Behaving Model-based (Goal-directed)

  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.

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

• Reaction Time in Response to Stimuli With OCD Themes

  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.

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

• Strength of Frontal Arbitration Modulation of Basal Ganglia Habit Region.

  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.

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

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR

Device: transcranial Direct Current Stimulation (tDCS)

OCD subjects

ACTIVE COMPARATOR

Device: transcranial Direct Current Stimulation (tDCS)

Interventions

transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Healthy subjects; OCD subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• males and females age 18-65 years with signed informed consent and IQ greater than 80 on WASI.
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Reza Tadayon Nejad
• Organization: UCLA

rtadayonnejad@mednet.ucla.edu

3102066389

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Psychiatry

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: July 15, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)