An interventional study of Active transcranial direct current stimulation and Sham transcranial direct current stimulation in Obsessive Compulsive Disorder (OCD), sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Yale University · Not applicable, Interventional, and Basic science
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).
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.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 180 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Participant Inclusion Criteria would include:
Obsessive-compulsive disorder (OCD) Inclusion Criteria would include:
Exclusion Criteria:
All Participant Exclusion Criteria would include:
Non-Clinical Control Exclusion Criteria would include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active transcranial direct current stimulation
Current will be ramped in and out for 30 seconds followed by a 20-minute period during which no stimulation will be delivered.
Device: Sham transcranial direct current 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.
Also known as: 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.
Also known as: Placebo transcranial electric stimulation
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).
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.
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.
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.
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.
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.
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)
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.
Plan to share: Yes — Raw de-identified data will be shared using the National Data Archive.
Time frame: IPD will be shared within one year of study completion.
Access criteria: Access to IPD will be public per NDA guidelines.
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Obsessive-Compulsive Disorder →