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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.

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

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

Other trials in United States

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.

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 groups in NCT05521074
Study groupRoleWhat they receive
Active tDCS administered before extinction phaseExperimentalThe 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 phaseExperimentalThe 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 phaseExperimentalThe 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 tDCSSham comparatorSham 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.

  1. 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)

  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.

  1. First posted30 Aug 2022
  2. Study start15 Sep 2022
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
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
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.

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.

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