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Obsessive-Compulsive DisorderNCT03572543

Enhancement of Therapeutic Learning in OCD Using tDCS

A study testing tDCS in people with Obsessive-Compulsive Disorder, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
15 Sep 2015to 7 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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;
  • Recent (< 8 weeks) change in psychotherapy - i.e. no recently instituted cognitive behavioral therapy will be permitted, but ongoing therapy of long duration will not constitute an exclusion;
  • OCD symptoms that cannot be provoked with in vivo exposures in a laboratory environment

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Connecticut Mental Health Center

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Enhancement of Therapeutic Learning in Obsessive-compulsive Disorder Using Transcranial Direct Current Stimulation

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.

Read the detailed description

Most effective behavioral treatments of disordered anxiety involve repeated exposure to feared stimuli, which often results in systematic reductions in fearful responding to said stimuli. It is believed that this process results from successful fear extinction, a well-characterized learning process that is mediated by fear extinction brain circuitry. Namely, fear extinction is an inhibitory learning process that requires activation and plasticity within a variety of brain regions, including the medial prefrontal cortex (mPFC), which can exert inhibitory control over fearful responding and parts of the brain that drive said responding. Behavioral treatments of disordered anxiety, while effective, have serious limitations; many patients fail to respond at all or only partially respond to exposure-based treatments. One candidate reason for this is deficits in fear extinction learning or memory processes. The proposed study aims to examine the effects of non-invasive neuromodulation - namely, multifocal transcranial direct current stimulation (tDCS) targeting the mPFC - on therapeutic learning and memory among adults diagnosed with obsessive-compulsive disorder (OCD).

This study will recruit 26 subjects with OCD to complete a two-day experimental protocol to examine the effects of tDCS on therapeutic learning and memory, which will be measured with an exposure and response prevention laboratory challenge. On Day 1, OCD subjects will be randomized (1:1, double-blind) to receive Active (n = 13) or Sham (n = 13) tDCS prior to completing five 10-minute in vivo exposure exercises to assess the effects of tDCS on the acquisition of therapeutic learning. Subjects and raters (including those directing exposure sessions) will be blind to allocation. On Day 2, OCD subjects will return to complete five additional exposure trials to examine the effects of tDCS on recall of therapeutic learning. Subjective ratings of emotional distress (0-100) will be collected at baseline, before and after tDCS, and during each minute of each exposure trial. It is hypothesized that tDCS will improve the acquisition and recall of therapeutic learning (Aim 4); that participants randomized to Active tDCS would show more rapid reductions in subjective distress and would recall therapeutic learning on Day 2 when compared to participants randomized that Sham tDCS.

tDCS will be delivered using an 8-channel Starstim transcranial electric stimulator from Neuroelectrics. To target the mPFC, the anodal electrode will be placed over the frontal pole (Fpz, 10-20 EEG landmarks) and will be surrounded by five return (cathodal) electrodes in a circumferential array (AF7, AF8, F3, Fz, and F4). Subjects in the Active tDCS condition will receive 20 minutes of direct current stimulation for 20 minutes; current will be ramped in and out for 30 seconds at the beginning and end of the 20-minute period. Subjects in the Sham tDCS condition will receive the same electrode placement and ramping procedures, but no current will be delivered between ramping.

Linear mixed modeling will be used to assess within and between-trial exposure-relevant learning. Power analyses suggest that a sample of 24 (12 per condition) would adequately power a priori analyses when using linear mixed modeling. Mixed ANOVA will be used to assess recall of exposure-relevant learning. The proposed study will provide important preliminary data to examine the potential for medial prefrontal tDCS to augment exposure-relevant therapeutic learning.

Being tested
tDCS
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    Also called transcranial direct current stimulation, transcranial electrical stimulation, Starstim®

    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.

Study groups in NCT03572543
Study groupRoleWhat they receive
Active tDCSActive comparatorCurrent 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.
Receives: Device: tDCS
Sham tDCSSham comparatorCurrent 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.
Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Units of Distress

    0-100 subjective distress self-report rating

    Measured: Collected every minute up through 50 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2018
  2. Study start15 Sep 2015
  3. Primary completion7 Sep 2017
  4. Study completion7 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03572543
Sponsor's protocol ID
1412015006_a
Other IDs
1K23MH111977
Status last verified
Feb 2022
First submitted
19 Jun 2018
Last updated
17 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34464485

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Obsessive-Compulsive Disorder, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Units of Distress (time frame: Collected every minute up through 50 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03572543, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.

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