Frontopolar tDCS to improve safety learning and extinction in OCD

Characterization and Modulation of Functional Connectivity and Fear Extinction Abnormalities in Obsessive-Compulsive Disorder

This will test whether brief frontopolar transcranial direct current stimulation (tDCS) can help adults with OCD improve extinction learning and safety-signal processing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06834217 on ClinicalTrials.gov

What this trial studies

Researchers will enroll 180 adults (120 with OCD, 60 matched controls) for a three-day, in-person experiment combining fMRI, fear-conditioning/extinction tasks, and physiological measures such as skin conductance and threat-expectancy ratings. On day 1 participants undergo structural and resting-state fMRI and Pavlovian conditioning to establish fear and safety cues. On day 2 OCD participants are randomized, double-blind, to receive either active or sham frontopolar tDCS during extinction training. The team will examine whether OCD is linked to dysconnectivity between the default mode and salience networks and whether tDCS normalizes connectivity and improves extinction-related learning and responding.

Who should consider this trial

Good fit: Adults 18 or older with a primary diagnosis of OCD, at least one year of symptoms, currently symptomatic, and on stable or no psychiatric treatment for at least eight weeks would be eligible.

Not a fit: People with bipolar disorder, psychotic disorders, active severe substance use, major neurological disease, significant traumatic brain injury, pregnancy, or other excluded conditions are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could improve the brain's ability to learn safety during exposure-based treatment and thereby enhance outcomes for people with OCD.

How similar studies have performed: Prior laboratory and small clinical studies have shown that tDCS can modulate learning, memory, and network connectivity, but clinical evidence for lasting benefits in OCD is limited and mixed.

Eligibility criteria

Inclusion Criteria:

* All Participant Inclusion Criteria would include:

  1. 18 years of age or older
  2. speak English fluently, and
  3. able to provide written and verbal informed consent.
* Obsessive-compulsive disorder (OCD) Inclusion Criteria would include:

  1. meet criteria for OCD as determined by structured clinical interview
  2. exhibit significant current symptoms of OCD
  3. report duration of OCD symptoms of at least 1-year
  4. OCD symptoms are primary or co-primary relative to other psychiatric diagnoses
  5. stable psychiatric treatment (≥8-weeks) or no active treatment.

Exclusion Criteria:

* All Participant Exclusion Criteria would include:

  1. active severe substance use disorder(s)
  2. acute suicidality
  3. history of bipolar or psychotic disorder(s)
  4. significant developmental disabilities
  5. loss of consciousness \> 10 minutes
  6. history of traumatic brain injury
  7. major neurological disease
  8. a positive pregnancy test
  9. other brain stimulation or magnetic resonance imaging contraindications
  10. new psychological treatment within the past 8 weeks
  11. active anxiolytic medication use (e.g., benzodiazepine).
* Non-Clinical Control Exclusion Criteria would include:

  1. meet current criteria for a psychiatric disorder as determined by structured clinical interview
  2. active-psychotropic medications.

Where this trial is running

New Haven, Connecticut

• Temple Medical Center — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Thomas Adams, PhD

Conditions Obsessive Compulsive Disorder; Anxiety Disorders; Mental Disorders; Obsessive-Compulsive Disorder