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.
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;
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- 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
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.
- Conditions
- Obsessive-Compulsive Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted28 Jun 2018
- Study start15 Sep 2015
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Thomas Adams, PhD, Principal investigator, Yale University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Therapeutic Learning in Obsessive-compulsive Disorder Using Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT03572543
- Acronym / sponsor ID
- 1412015006_a
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCSCurrent 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. |
| Sham tDCS | Sham comparator | Device: tDCSCurrent 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: 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. | Device | Active tDCS, Sham tDCS |
Primary outcome
Subjective Units of Distress
Time frame: Collected every minute up through 50 minutes
0-100 subjective distress self-report rating
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Derived from this study: PubMed 34464485Adams 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Adams, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
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.