NCT03572543

Brief Summary

Psychiatric disorders characterized by pathological fear and anxiety are common and often disabling. Despite their limitations, exposure therapies are among the most efficacious treatments for these disorders. Extinction learning is thought to be a core mechanism of therapeutic exposure. Extinction learning is mediated by a well-defined circuit encompassing the medial prefrontal cortex (mPFC), amygdala, and hippocampus. This raises the exciting possibility that direct engagement of this circuitry might enhance the response to therapeutic exposure. Transcranial direct current stimulation (tDCS) is a neuromodulation technology that can augment brain plasticity, learning, and memory. The proposed study will evaluate whether tDCS can improve therapeutic learning and memory processes among participants diagnosed with obsessive-compulsive disorder (OCD) This study aims to use tDCS to improve learning and memory processes within the context of an exposure laboratory challenge. Participants diagnosed with OCD will complete a two-day experimental study. On day 1, participants will receive sham (placebo) or active tDCS followed by approximately 50-minutes of individualized exposure. on day 2, participants will return to complete an additional 50-minutes of exposure. Subjective distress will be repeatedly monitored during exposure to allow for the modeling of within-trail and within-session learning and between-session recall of learning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

June 19, 2018

Last Update Submit

February 16, 2022

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Subjective Units of Distress

    0-100 subjective distress self-report rating

    Collected every minute up through 50 minutes

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Current will be ramped in/out for 30 seconds at the begging and end of a 20-minute period and a constant current will be delivered for the 20-minutes between ramping.

Device: tDCS

Sham tDCS

SHAM COMPARATOR

Current will be ramped in/out for 30 seconds at the begging and end of a 20-minute period during which no stimulation will be delivered.

Device: tDCS

Interventions

tDCSDEVICE

Subjects will receive 20 minutes of multifocal transcranial direct current stimulation. The anode will be placed over the frontal pole (Fpz, 10-20 EEG) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in/out at the begging and end of the 20-minutes of stimulation over the course of 30 seconds.

Also known as: transcranial direct current stimulation, transcranial electrical stimulation, Starstim®
Active tDCSSham tDCS

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to provide informed consent (as established by clinical interview), and voluntary, signed informed consent prior to the performance of any study-specific procedures;
  • Ability and willingness to perform study-relevant clinical assessments and tDCS;
  • Age 18-55;
  • Medication free or stable (\> 4 weeks) medication(s).
  • A Diagnostic and Statistical Manual diagnosis of OCD; and
  • Clinically significant obsessions and compulsions of at least moderate severity, as established by a score of at least 16 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) during initial screening.

You may not qualify if:

  • Any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment;
  • Any substance dependence or severe substance abuse within the past 6 months;
  • Daily use of psychotropic medications that substantially lower seizure threshold (e.g., clozapine);
  • Daily use of psychotropic drugs that may interfere with extinction learning (e.g., anxiolytics);
  • Any history of a psychotic disorder or of mania;
  • Current active suicidal ideation or any suicidal intent;
  • Any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness, or of psychosurgery;
  • Any history of epilepsy;
  • Pregnancy;
  • Any metal in the body or other contraindication to MRI scanning or tDCS;
  • Any history of adverse effects to brain stimulation;
  • OCD symptoms that cannot be provoked with in vivo exposures in a laboratory environment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Adams TG, Cisler JM, Kelmendi B, George JR, Kichuk SA, Averill CL, Anticevic A, Abdallah CG, Pittenger C. Transcranial direct current stimulation targeting the medial prefrontal cortex modulates functional connectivity and enhances safety learning in obsessive-compulsive disorder: Results from two pilot studies. Depress Anxiety. 2022 Jan;39(1):37-48. doi: 10.1002/da.23212. Epub 2021 Aug 31.

    PMID: 34464485DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Thomas Adams, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

June 28, 2018

Study Start

September 15, 2015

Primary Completion

September 7, 2017

Study Completion

September 7, 2017

Last Updated

February 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

IPD will be shared with other researchers upon request and review by the PI and relevant collaborators. Data will be stored on a yet to be determined data sharing repository supported by the National Institutes of Health.

Shared Documents
SAP, ANALYTIC CODE
Time Frame
Data will be made available following study publication.

Locations

US(1)