Obsessive-Compulsive DisorderNCT05521074
Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD
A study testing Active tDCS in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators want to learn more about how human beings learn not to fear and the impact of changing the fear network in the brain using transcranial Direct Current Stimulation (tDCS) in individuals with obsessive compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fluent in English, willing to provide informed consent, and willing to comply with the study protocol
- Primary OCD that causes at least moderate distress and/or impairment (Y-BOCS total score ≥ 16)
- Comfortable and capable of using a computer and completing computerized tasks
Who cannot join
- History of head injury resulting in prolonged (i.e., >1h) loss of consciousness and/or neurological sequelae; history of stroke; signs of increased intracranial pressure; prior neurosurgical procedure (e.g., DBS, aneurysm clips)
- Contraindications to participate in tDCS including: metallic implants in head or neck; ventriculoperitoneal (VP) shunts; pacemakers; pregnancy; epilepsy.
- Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to participate in the study
- Impaired (or uncorrected) vision that would interfere with participation.
- Current clinically significant suicidality that requires psychiatric hospitalization, as indicated by clinical judgment.
- Current substance use disorder (within the past 12 months)
Show all 10Show fewer
- Lifetime manic episode or psychosis
- Documented resistance to 4 or more valid pharmacological trials and previous treatment with ≥12 sessions of cognitive behavioral therapy for OCD with no response (or worsening symptoms)
- Use of most psychotropic medications (e.g., SSRIs and atypical antipsychotics) will be allowed. However, use of benzodiazepines within 2 weeks prior to the study is exclusionary (and participants will be asked to refrain from use of such medications during the study as they may interfere with the fear extinction paradigm).
- Unable to obtain low enough impedance values to ensure safe and effective application of tDCS/EEG.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD: Towards Rational Design of Combination Therapies
The investigators want to learn more about how human beings learn not to fear and the impact of changing the fear network in the brain using transcranial Direct Current Stimulation (tDCS) in individuals with obsessive compulsive disorder (OCD). The investigators hope this study will help us understand how future treatments can help patients with OCD better control unwanted fear.
Read the detailed description
To address this question behaviorally and biologically, the investigators will use a, 2-day fear extinction paradigm while measuring behavioral psychophysiology (skin conductance response [SCR]) and neurophysiology (electroencephalography [EEG]). On Day 1 participants will undergo 1) habituation, 2) fear conditioning, and 3) extinction learning. On Day 2 they will undergo 4) extinction recall, and 5) reinstatement. SCR and EEG will be measured in both sessions. The investigators propose to investigate whether inhibitory tDCS to the pre-SMA before, during, or after fear extinction significantly 1) enhances the recall of extinction learning and 2) reduces fronto-medial theta power during extinction recall. Participants will be randomized to one of the following four conditions: active tDCS before, during, or after extinction learning, or sham tDCS. The fear extinction paradigm serves as a proxy of exposure-based CBT for OCD. Defining the combination protocol that optimally and significantly increases extinction recall behaviorally (psychophysiology) in OCD, will have critical implications for the mechanistically informed development of tDCS-augmented CBT for OCD. EEG measures will provide a response biomarker to characterize target engagement neurophysiologically. This is particularly relevant given EEG's ease of use, relatively low cost, and potential for greater translation to the clinic. Also, the higher signal-to-noise ratio (SNR) of EEG compared to SCR is a strength. Taken together, these data should reveal treatment targets, define optimal therapeutic protocols, and provide the foundation for a future clinical trial to test the synergistic efficacy of combined tDCS-CBT for OCD.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Obsessive-Compulsive Disorder, OCD, Fear extinction, tDCS, transcranial Direct Current Stimulation, Randomized controlled trial, Fear conditioning
- 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.
Active tDCSDevice
The investigators will use commercially available tDCS equipment (Neuroelectrics©, Barcelona, Spain). The cathode will be placed over the pre-SMA using the 10-20 EEG system and the anode will be on the right deltoid.
Sham tDCSDevice
The investigators will use commercially available tDCS equipment (Neuroelectrics©, Barcelona, Spain). The cathode will be placed over the pre-SMA using the 10-20 EEG system and the anode will be on the right deltoid. tDCS will not be active in this condition.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS administered before extinction phase | Experimental | The investigators will stimulate using 2mA of direct current during 20 min before the extinction phase of the fear conditioning and extinction paradigm. Receives: Device: Active tDCS |
| Active tDCS administered during extinction phase | Experimental | The investigators will stimulate using 2mA of direct current during 20 min during the extinction phase of the fear conditioning and extinction paradigm. Receives: Device: Active tDCS |
| Active tDCS administered after extinction phase | Experimental | The investigators will stimulate using 2mA of direct current during 20 min after the extinction phase of the fear conditioning and extinction paradigm. Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | Sham will consist of a ramp up and down of activity (from 0 to 2mA and back to 0mA) in the first 30sec and again in the last 30 sec of the 20min stimulation period (which will occur before/during/after the extinction phase). No active tDCS will occur. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Frontomedial Theta Power (EEG) to the Conditioned Stimulus (CS+) Versus the Unconditioned Stimulus (CS-) Between tDCS Conditions During Extinction Recall
Greater reduction in the difference in frontomedial theta event-related spectral perturbation (ERSP) between CS+ vs CS- indicates more complete neural extinction of the conditioned fear response, reflecting diminished differential threat processing such that the previously conditioned stimulus is being processed more similarly to the safe stimulus.
Measured: Extinction Recall Phase (Day 2)
Difference in the Square Root Skin Conductance Response (SCR) to the Conditioned Stimulus (CS+) Versus the Unconditioned Stimulus (CS-) Between tDCS Conditions During the First 12 Trials of Extinction Recall
Higher skin conductance (microSiemens) indicates greater fear intensity.
Measured: Extinction Recall Phase (Day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start15 Sep 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for OCD Research
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
- Investigators
- Joan Camprodon, MD, MPH, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521074
- Sponsor's protocol ID
- 2022P001065
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2022
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The investigators do not have specific plans to share individual participant data in order to preserve the confidentiality of our participants. Any data that is shared would only be done so after executing a formal Data Use Agreement from Massachusetts General Hospital.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD: Towards Rational Design of Combination Therapies
- ClinicalTrials.gov ID
- NCT05521074
- Acronym / sponsor ID
- 2022P001065
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, OCD, Fear extinction, tDCS, transcranial Direct Current Stimulation, Randomized controlled trial, Fear conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Foundation for OCD Research
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to learn more about how human beings learn not to fear and the impact of changing the fear network in the brain using transcranial Direct Current Stimulation (tDCS) in individuals with obsessive compulsive disorder (OCD). The investigators hope this study will help us understand how future treatments can help patients with OCD better control unwanted fear.
Detailed description
To address this question behaviorally and biologically, the investigators will use a, 2-day fear extinction paradigm while measuring behavioral psychophysiology (skin conductance response [SCR]) and neurophysiology (electroencephalography [EEG]). On Day 1 participants will undergo 1) habituation, 2) fear conditioning, and 3) extinction learning. On Day 2 they will undergo 4) extinction recall, and 5) reinstatement. SCR and EEG will be measured in both sessions. The investigators propose to investigate whether inhibitory tDCS to the pre-SMA before, during, or after fear extinction significantly 1) enhances the recall of extinction learning and 2) reduces fronto-medial theta power during extinction recall. Participants will be randomized to one of the following four conditions: active tDCS before, during, or after extinction learning, or sham tDCS. The fear extinction paradigm serves as a proxy of exposure-based CBT for OCD. Defining the combination protocol that optimally and significantly increases extinction recall behaviorally (psychophysiology) in OCD, will have critical implications for the mechanistically informed development of tDCS-augmented CBT for OCD. EEG measures will provide a response biomarker to characterize target engagement neurophysiologically. This is particularly relevant given EEG's ease of use, relatively low cost, and potential for greater translation to the clinic. Also, the higher signal-to-noise ratio (SNR) of EEG compared to SCR is a strength. Taken together, these data should reveal treatment targets, define optimal therapeutic protocols, and provide the foundation for a future clinical trial to test the synergistic efficacy of combined tDCS-CBT for OCD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active tDCS administered before extinction phase | Experimental | Device: Active tDCSThe investigators will stimulate using 2mA of direct current during 20 min before the extinction phase of the fear conditioning and extinction paradigm. |
| Active tDCS administered during extinction phase | Experimental | Device: Active tDCSThe investigators will stimulate using 2mA of direct current during 20 min during the extinction phase of the fear conditioning and extinction paradigm. |
| Active tDCS administered after extinction phase | Experimental | Device: Active tDCSThe investigators will stimulate using 2mA of direct current during 20 min after the extinction phase of the fear conditioning and extinction paradigm. |
| Sham tDCS | Sham comparator | Device: Sham tDCSSham will consist of a ramp up and down of activity (from 0 to 2mA and back to 0mA) in the first 30sec and again in the last 30 sec of the 20min stimulation period (which will occur before/during/after the extinction phase). No active tDCS will occur. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fluent in English, willing to provide informed consent, and willing to comply with the study protocol
- Primary OCD that causes at least moderate distress and/or impairment (Y-BOCS total score ≥ 16)
- Comfortable and capable of using a computer and completing computerized tasks
Key exclusion criteria (10 listed)
- History of head injury resulting in prolonged (i.e., >1h) loss of consciousness and/or neurological sequelae; history of stroke; signs of increased intracranial pressure; prior neurosurgical procedure (e.g., DBS, aneurysm clips)
- Contraindications to participate in tDCS including: metallic implants in head or neck; ventriculoperitoneal (VP) shunts; pacemakers; pregnancy; epilepsy.
- Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to participate in the study
- Impaired (or uncorrected) vision that would interfere with participation.
- Current clinically significant suicidality that requires psychiatric hospitalization, as indicated by clinical judgment.
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 tDCSThe investigators will use commercially available tDCS equipment (Neuroelectrics©, Barcelona, Spain). The cathode will be placed over the pre-SMA using the 10-20 EEG system and the anode will be on the right deltoid. | Device | Active tDCS administered after extinction phase, Active tDCS administered before extinction phase, Active tDCS administered during extinction phase |
| Sham tDCSThe investigators will use commercially available tDCS equipment (Neuroelectrics©, Barcelona, Spain). The cathode will be placed over the pre-SMA using the 10-20 EEG system and the anode will be on the right deltoid. tDCS will not be active in this condition. | Device | Sham tDCS |
Primary outcome
Difference in Frontomedial Theta Power (EEG) to the Conditioned Stimulus (CS+) Versus the Unconditioned Stimulus (CS-) Between tDCS Conditions During Extinction Recall
Time frame: Extinction Recall Phase (Day 2)
Greater reduction in the difference in frontomedial theta event-related spectral perturbation (ERSP) between CS+ vs CS- indicates more complete neural extinction of the conditioned fear response, reflecting diminished differential threat processing such that the previously conditioned stimulus is being processed more similarly to the safe stimulus.
Difference in the Square Root Skin Conductance Response (SCR) to the Conditioned Stimulus (CS+) Versus the Unconditioned Stimulus (CS-) Between tDCS Conditions During the First 12 Trials of Extinction Recall
Time frame: Extinction Recall Phase (Day 2)
Higher skin conductance (microSiemens) indicates greater fear intensity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Eligibility Interest FormLink provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators do not have specific plans to share individual participant data in order to preserve the confidentiality of our participants. Any data that is shared would only be done so after executing a formal Data Use Agreement from Massachusetts General Hospital.
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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.
Joan Camprodon, MD, MPH, PhD principal investigator
Massachusetts General Hospital
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 tDCS in people with Obsessive-Compulsive Disorder, run by Massachusetts General Hospital 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 3 inclusion and 10 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 4 Sep 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?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Frontomedial Theta Power (EEG) to the Conditioned Stimulus (CS+) Versus the Unconditioned Stimulus (CS-) Between tDCS Conditions During Extinction Recall (time frame: Extinction Recall Phase (Day 2)). The study lists 2 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 4 Sep 2026.