Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD

NCT05521074 | Completed DMC FDA Device

• 1 other identifier: 2022P001065
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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). The investigators hope this study will help us understand how future treatments can help patients with OCD better control unwanted fear.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; OCD; Fear extinction; tDCS; transcranial Direct Current Stimulation; Randomized controlled trial; Fear conditioning

Outcome Measures

Primary Outcomes (2)

• Difference in skin conductance response (SCR) to the conditioned stimulus (CS+) versus the unconditioned stimulus (CS-) between tDCS conditions during extinction recall

  Higher skin conductance (microSiemens) indicates greater fear intensity.

  Extinction Recall Phase (Day 2)

• Difference in frontomedial theta power (EEG) to the conditioned stimulus (CS+) versus the unconditioned stimulus (CS-) between tDCS conditions during extinction recall

  Greater reduction of frontomedial theta power (microvolts) indicates stronger extinction recall.

  Extinction Recall Phase (Day 2)

Study Arms (4)

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.

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.

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.

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.

Device: Sham tDCS

Interventions

Active tDCS DEVICE

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.

Active tDCS administered after extinction phase; Active tDCS administered before extinction phase; Active tDCS administered during extinction phase

Sham tDCS DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)
• Unable to obtain low enough impedance values to ensure safe and effective application of tDCS/EEG.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Foundation for OCD Research: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Eligibility Interest Form

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Joan Camprodon, MD, MPH, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 30, 2022
• Study Start: September 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)