Obsessive Compulsive Disorder (OCD)NCT06834217
Transcranial Direct Current Stimulation and Extinction in Obsessive Compulsive Disorder
A study testing Active transcranial direct current stimulation in people with Obsessive Compulsive Disorder (OCD), run by Yale University at 1 site in United States.
Trial summary
Obsessive-compulsive disorder (OCD) is associated with substantial impairments in quality of life and is among the most disabling psychiatric disorders. Exposure therapy is among the first-line of treatments for obsessive-compulsive disorder (OCD) . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Active transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participant Inclusion Criteria would include:
- 18 years of age or older
- speak English fluently, and
- able to provide written and verbal informed consent.
- Obsessive-compulsive disorder (OCD) Inclusion Criteria would include:
- meet criteria for OCD as determined by structured clinical interview
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- exhibit significant current symptoms of OCD
- report duration of OCD symptoms of at least 1-year
- OCD symptoms are primary or co-primary relative to other psychiatric diagnoses
- stable psychiatric treatment (≥8-weeks) or no active treatment.
- exhibit significant current symptoms of OCD as determined by the Dimensional Obsessive-Compulsive Scale (DOCS) (≥18).
Who cannot join
- All Participant Exclusion Criteria would include:
- active severe substance use disorder(s)
- acute suicidality
- history of bipolar or psychotic disorder(s)
- significant developmental disabilities
- loss of consciousness > 10 minutes
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- history of traumatic brain injury
- major neurological disease
- a positive pregnancy test
- other brain stimulation or magnetic resonance imaging contraindications
- new psychological treatment within the past 8 weeks
- daily anxiolytic medication use (e.g., benzodiazepine).
- Non-Clinical Control Exclusion Criteria would include:
- meet current criteria for a psychiatric disorder as determined by structured clinical interview
- active-psychotropic medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ava Reker, B.A. contact
United States1 site, 1 recruiting
- Recruiting
Temple Medical Center
New Haven, Connecticut, 06511
Ava Reker, B.A., 2037854575, ava.reker@yale.edu
Thomas Adams, PhD
About this study
Official title: Characterization and Modulation of Functional Connectivity and Fear Extinction Abnormalities in Obsessive-Compulsive Disorder
Obsessive-compulsive disorder (OCD) is associated with substantial impairments in quality of life and is among the most disabling psychiatric disorders. Exposure therapy is among the first-line of treatments for obsessive-compulsive disorder (OCD) . Extinction learning is thought to be a core mechanism of therapeutic exposure. Fear and safety signal learning are traditionally associated with activity and connectivity within the canonical corticolimbic "fear circuit", which includes the amygdala, medial prefrontal cortex (mPFC), and hippocampus. Transcranial direct current stimulation (tDCS) is a neuromodulation technology that can augment brain plasticity, learning, and memory. The proposed study will test if obsessive-compulsive disorder (OCD) is associated with inhibitory safety learning deficits and if transcranial direct current stimulation (tDCS) normalizes functional connectivity and safety signal processing to recover extinction deficits in obsessive-compulsive disorder (OCD).
Read the detailed description
The proposed study aims to test if obsessive-compulsive disorder (OCD) is associated with dyconnectivity between the default mode network (DMN) and salience network (SN) (Aim 1), if obsessive-compulsive disorder (OCD) is associated with extinction learning deficits (Aim 2), and if front-polar transcranial direct current stimulation (tDCS) normalizes dysconnectivity and extinction learning in obsessive-compulsive disorder (OCD) (Aim 3).
This study will randomize 180 adults with obsessive-compulsive disorder (OCD) (n=120) and matched non-clinical controls (n=60) for aims 1-3. After providing informed consent, baseline screening, and clinical characterization, participants would complete a three-day experiment. On day 1, all participants would complete structural and resting functional magnetic resonance imaging (fMRI) scans followed by standardized fear conditioning procedures with functional magnetic resonance imaging (fMRI) and measures of fearful responding (i.e., skin conductance response [SCR] and threat expectancy ratings). Participants would be conditioned to two different conditioned stimuli (CS+; CS+A and CS+B) by pairing each CS+ with an aversive shock (unconditioned stimulus [US]) at a 50% schedule of reinforcement. A third, neutral stimulus (CS-), would never be paired with the US. On day 2, participants would complete extinction training for the CS+A, then participants with obsessive-compulsive disorder (OCD) would be randomized (1:1, stratified, double-blind) to receive active or sham multifocal frontopolar transcranial direct current stimulation (tDCS) with resting functional magnetic resonance imaging (fMRI) before, during, and after transcranial direct current stimulation (tDCS). Blocked randomization, stratified by sex, age, and current psychiatric medication usage, would be implemented by an individual who would have no direct contact with the participants and no knowledge of the assignment to the group labels. Participants and assessors will be blind to allocation. All non-clinical controls would not receive any transcranial direct current stimulation (tDCS). Next, extinction training for the CS+B would be completed. On day 3, return of fear testing (spontaneous recovery, context renewal, and reinstatement) would be completed.
Transcranial direct current stimulation (tDCS) would be administered using a battery-driven, Soterix© transcranial electric stimulator. A single anode would be placed over the frontal pole and five return electrodes would be arranged in a circumferential array. Positively charged e-fields produced by this montage would concentrate over the medial frontal pole. Participants in the active-transcranial direct current stimulation (tDCS) condition would receive 20-minutes of offline (while resting with eyes open) frontopolar transcranial direct current stimulation (tDCS) (30-seconds ramp in/out). Participants in the sham-transcranial direct current stimulation (tDCS) condition would receive 30-seconds ramp in/out followed by 20-minutes of no stimulation.
Brain imaging would be performed with a Siemens MAGNETOM Prisma 3T scanner using a 64-channel phased array padded head coil. A vitamin E capsule would be secured to the outer center of the transcranial direct current stimulation (tDCS) anode to create a precise contrast in structural magnetic resonance imaging (MRI). After localization, all participants would undergo anatomical imaging for registration and normalization purposes. 6-min of rs-functional magnetic resonance imaging (fMRI) data would be collected immediately before and after frontopolar transcranial direct current stimulation (tDCS) and four ~5-min blocks rs-functional magnetic resonance imaging (fMRI) sequences would be collected during the 20-min of active- or sham-transcranial direct current stimulation (tDCS) to characterize temporal elements of dosage (e.g., linear change in rs-FC over the time course of transcranial direct current stimulation [tDCS] administration) in exploratory analyses.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Active transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- Anxiety Disorders, Mental Disorders, Obsessive-Compulsive Disorder
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial direct current stimulationDevice
Also called Transcranial electric stimulation
Multifocal transcranial direct current stimulation will be delivered. The anode will be placed over the frontal pole (Fpz, 10-20 electroencephalogram [EEG]) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in and out for 30 seconds at the beginning and end of a 20-minute stimulation period.
Sham transcranial direct current stimulationDevice
Also called Placebo transcranial electric stimulation
Multifocal transcranial direct current stimulation will be delivered. The anode will be placed over the frontal pole (Fpz, 10-20 electroencephalogram [EEG]) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in and out for 30 seconds at the beginning of a 20-minute period.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation | Active comparator | Current will be ramped in/out for 30 seconds at the beginning and end of a 20-minute period and a constant current will be delivered for the 20-minutes between ramping. Receives: Device: Active transcranial direct current stimulation |
| Sham transcranial direct current stimulation | Sham comparator | Current will be ramped in and out for 30 seconds followed by a 20-minute period during which no stimulation will be delivered. Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level-dependent (BOLD) response to create functional brain activation maps
Brain activity will be estimated with blood oxygen level-dependent (BOLD) response, which will be measured with magnetic resonance imaging (MRI).
Measured: Blood oxygen level-dependent (BOLD) will be measured across 3 daily scan sessions separated by ~24 hours each; data will be reported from all 3 sessions.
Skin conductance response (SCR) will be measured by collecting electrodermal activity data from the left hand
Skin conductance data will be used as an index of anxious reactivity to experimental cues.
Measured: Skin conductance will be measured across all 3 scan sessions, separated by ~24 hours each; data will be reported from all 3 sessions.
Threat expectancies will be measured by asking participants to rate the probability of receiving a shock using a 0-100 scale with zero equal to 0% chance and 100 equal to 100% chance; higher values are indicative of worse anxious reactivity
Threat expectancies will be used as an index of anxious reactivity to experimental cues.
Measured: Threat expectancies will be assessed at the beginning and end of each of the 3 scan session, separated by ~24-hours each; data will be reported from all 3 sessions.
Functional brain connectivity will be measured blood oxygen level dependent (BOLD) response
Correlations in brain activity between regions and networks measured with blood oxygen level dependent (BOLD) response captured with magnetic resonance imaging (MRI)
Measured: Resting functional connectivity will be measured at baseline during first scan session and during transcranial direct current stimulation in the second scan session; scan sessions will be separated by ~24 hours; data from both sessions will be reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start12 Sep 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies 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
- Model description
- Patients with OCD will be randomized to receive active (real) or sham (placebo) multifocal frontopolar transcranial direct current stimulation (tDCS). All non-clinical controls would not receive any transcranial direct current stimulation (tDCS).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas Adams, PhD, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834217
- Sponsor's protocol ID
- 2000039024
- Other IDs
- R01MH137471
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Raw de-identified data will be shared using the National Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Modulation of Functional Connectivity and Fear Extinction Abnormalities in Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06834217
- Acronym / sponsor ID
- 2000039024
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Anxiety Disorders, Mental Disorders, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 19 Feb 2025 (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.
Obsessive-compulsive disorder (OCD) is associated with substantial impairments in quality of life and is among the most disabling psychiatric disorders. Exposure therapy is among the first-line of treatments for obsessive-compulsive disorder (OCD) . Extinction learning is thought to be a core mechanism of therapeutic exposure. Fear and safety signal learning are traditionally associated with activity and connectivity within the canonical corticolimbic "fear circuit", which includes the amygdala, medial prefrontal cortex (mPFC), and hippocampus. Transcranial direct current stimulation (tDCS) is a neuromodulation technology that can augment brain plasticity, learning, and memory. The proposed study will test if obsessive-compulsive disorder (OCD) is associated with inhibitory safety learning deficits and if transcranial direct current stimulation (tDCS) normalizes functional connectivity and safety signal processing to recover extinction deficits in obsessive-compulsive disorder (OCD).
Detailed description
The proposed study aims to test if obsessive-compulsive disorder (OCD) is associated with dyconnectivity between the default mode network (DMN) and salience network (SN) (Aim 1), if obsessive-compulsive disorder (OCD) is associated with extinction learning deficits (Aim 2), and if front-polar transcranial direct current stimulation (tDCS) normalizes dysconnectivity and extinction learning in obsessive-compulsive disorder (OCD) (Aim 3).
This study will randomize 180 adults with obsessive-compulsive disorder (OCD) (n=120) and matched non-clinical controls (n=60) for aims 1-3. After providing informed consent, baseline screening, and clinical characterization, participants would complete a three-day experiment. On day 1, all participants would complete structural and resting functional magnetic resonance imaging (fMRI) scans followed by standardized fear conditioning procedures with functional magnetic resonance imaging (fMRI) and measures of fearful responding (i.e., skin conductance response [SCR] and threat expectancy ratings). Participants would be conditioned to two different conditioned stimuli (CS+; CS+A and CS+B) by pairing each CS+ with an aversive shock (unconditioned stimulus [US]) at a 50% schedule of reinforcement. A third, neutral stimulus (CS-), would never be paired with the US. On day 2, participants would complete extinction training for the CS+A, then participants with obsessive-compulsive disorder (OCD) would be randomized (1:1, stratified, double-blind) to receive active or sham multifocal frontopolar transcranial direct current stimulation (tDCS) with resting functional magnetic resonance imaging (fMRI) before, during, and after transcranial direct current stimulation (tDCS). Blocked randomization, stratified by sex, age, and current psychiatric medication usage, would be implemented by an individual who would have no direct contact with the participants and no knowledge of the assignment to the group labels. Participants and assessors will be blind to allocation. All non-clinical controls would not receive any transcranial direct current stimulation (tDCS). Next, extinction training for the CS+B would be completed. On day 3, return of fear testing (spontaneous recovery, context renewal, and reinstatement) would be completed.
Transcranial direct current stimulation (tDCS) would be administered using a battery-driven, Soterix© transcranial electric stimulator. A single anode would be placed over the frontal pole and five return electrodes would be arranged in a circumferential array. Positively charged e-fields produced by this montage would concentrate over the medial frontal pole. Participants in the active-transcranial direct current stimulation (tDCS) condition would receive 20-minutes of offline (while resting with eyes open) frontopolar transcranial direct current stimulation (tDCS) (30-seconds ramp in/out). Participants in the sham-transcranial direct current stimulation (tDCS) condition would receive 30-seconds ramp in/out followed by 20-minutes of no stimulation.
Brain imaging would be performed with a Siemens MAGNETOM Prisma 3T scanner using a 64-channel phased array padded head coil. A vitamin E capsule would be secured to the outer center of the transcranial direct current stimulation (tDCS) anode to create a precise contrast in structural magnetic resonance imaging (MRI). After localization, all participants would undergo anatomical imaging for registration and normalization purposes. 6-min of rs-functional magnetic resonance imaging (fMRI) data would be collected immediately before and after frontopolar transcranial direct current stimulation (tDCS) and four ~5-min blocks rs-functional magnetic resonance imaging (fMRI) sequences would be collected during the 20-min of active- or sham-transcranial direct current stimulation (tDCS) to characterize temporal elements of dosage (e.g., linear change in rs-FC over the time course of transcranial direct current stimulation [tDCS] administration) in exploratory analyses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with OCD will be randomized to receive active (real) or sham (placebo) multifocal frontopolar transcranial direct current stimulation (tDCS). All non-clinical controls would not receive any transcranial direct current stimulation (tDCS).
| Arm | Type | Receives |
|---|---|---|
| Active transcranial direct current stimulation | Active comparator | Device: Active transcranial direct current stimulationCurrent will be ramped in/out for 30 seconds at the beginning and end of a 20-minute period and a constant current will be delivered for the 20-minutes between ramping. |
| Sham transcranial direct current stimulation | Sham comparator | Device: Sham transcranial direct current stimulationCurrent will be ramped in and out for 30 seconds followed by a 20-minute period during which no stimulation will be delivered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All Participant Inclusion Criteria would include:
- Obsessive-compulsive disorder (OCD) Inclusion Criteria would include:
Key exclusion criteria (15 listed)
- All Participant Exclusion Criteria would include:
- Non-Clinical Control Exclusion Criteria would include:
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 |
|---|---|---|
| Active transcranial direct current stimulationAlso: Transcranial electric stimulationMultifocal transcranial direct current stimulation will be delivered. The anode will be placed over the frontal pole (Fpz, 10-20 electroencephalogram [EEG]) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in and out for 30 seconds at the beginning and end of a 20-minute stimulation period. | Device | Active transcranial direct current stimulation |
| Sham transcranial direct current stimulationAlso: Placebo transcranial electric stimulationMultifocal transcranial direct current stimulation will be delivered. The anode will be placed over the frontal pole (Fpz, 10-20 electroencephalogram [EEG]) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in and out for 30 seconds at the beginning of a 20-minute period. | Device | Sham transcranial direct current stimulation |
Primary outcome
Blood oxygen level-dependent (BOLD) response to create functional brain activation maps
Time frame: Blood oxygen level-dependent (BOLD) will be measured across 3 daily scan sessions separated by ~24 hours each; data will be reported from all 3 sessions.
Brain activity will be estimated with blood oxygen level-dependent (BOLD) response, which will be measured with magnetic resonance imaging (MRI).
Skin conductance response (SCR) will be measured by collecting electrodermal activity data from the left hand
Time frame: Skin conductance will be measured across all 3 scan sessions, separated by ~24 hours each; data will be reported from all 3 sessions.
Skin conductance data will be used as an index of anxious reactivity to experimental cues.
Threat expectancies will be measured by asking participants to rate the probability of receiving a shock using a 0-100 scale with zero equal to 0% chance and 100 equal to 100% chance; higher values are indicative of worse anxious reactivity
Time frame: Threat expectancies will be assessed at the beginning and end of each of the 3 scan session, separated by ~24-hours each; data will be reported from all 3 sessions.
Threat expectancies will be used as an index of anxious reactivity to experimental cues.
Functional brain connectivity will be measured blood oxygen level dependent (BOLD) response
Time frame: Resting functional connectivity will be measured at baseline during first scan session and during transcranial direct current stimulation in the second scan session; scan sessions will be separated by ~24 hours; data from both sessions will be reported.
Correlations in brain activity between regions and networks measured with blood oxygen level dependent (BOLD) response captured with magnetic resonance imaging (MRI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. Raw de-identified data will be shared using the National Data Archive.
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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.
Ava Reker, B.A. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation in people with Obsessive Compulsive Disorder (OCD), 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Adams, PhD ((203) 974-7523, thomas.adamsjr@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen level-dependent (BOLD) response to create functional brain activation maps (time frame: Blood oxygen level-dependent (BOLD) will be measured across 3 daily scan sessions separated by ~24 hours each; data will be reported from all 3 sessions.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.