Transcranial Direct Current Stimulation and Extinction in Obsessive Compulsive Disorder

NCT06834217 | Recruiting FDA Device

• 2 other identifiers: 2000039024R01MH137471
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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) . 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).

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

Anxiety Disorders; Mental Disorders; Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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)

  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.

Study Arms (2)

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.

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.

Device: Sham transcranial direct current stimulation

Interventions

Sham transcranial direct current stimulation DEVICE

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

Sham transcranial direct current stimulation

Active transcranial direct current stimulation DEVICE

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

Active transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age or older
• speak English fluently, and
• able to provide written and verbal informed consent.
• meet criteria for OCD as determined by structured clinical interview
• 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.

You may not qualify if:

• active severe substance use disorder(s)
• acute suicidality
• history of bipolar or psychotic disorder(s)
• significant developmental disabilities
• loss of consciousness \> 10 minutes
• 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
• active anxiolytic medication use (e.g., benzodiazepine).
• meet current criteria for a psychiatric disorder as determined by structured clinical interview
• active-psychotropic medications.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Temple Medical Center

New Haven, Connecticut, 06511, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders

Central Study Contacts

Thomas Adams, PhD

CONTACT

(203) 974-7523; thomas.adamsjr@yale.edu

Ava Reker, B.A.

CONTACT

ava.reker@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 19, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be shared within one year of study completion.
• Access Criteria: Access to IPD will be public per NDA guidelines.

Locations

US (1)