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Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, OCD, Fear extinction, tDCS, transcranial Direct Current Stimulation, Randomized controlled trial, Fear conditioning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Active tDCS administered before extinction phase

Active tDCS administered during extinction phase

Active tDCS administered after extinction phase

Sham tDCS

Arm Description

The investigators will stimulate using 2mA of direct current during 20 min before the extinction phase of the fear conditioning and extinction paradigm.

The investigators will stimulate using 2mA of direct current during 20 min during the extinction phase of the fear conditioning and extinction paradigm.

The investigators will stimulate using 2mA of direct current during 20 min after the extinction phase of the fear conditioning and extinction paradigm.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2022
Last Updated
October 10, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Foundation for OCD Research
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1. Study Identification

Unique Protocol Identification Number
NCT05521074
Brief Title
Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD
Official Title
Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD: Towards Rational Design of Combination Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Foundation for OCD Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, OCD, Fear extinction, tDCS, transcranial Direct Current Stimulation, Randomized controlled trial, Fear conditioning

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS administered before extinction phase
Arm Type
Experimental
Arm Description
The investigators will stimulate using 2mA of direct current during 20 min before the extinction phase of the fear conditioning and extinction paradigm.
Arm Title
Active tDCS administered during extinction phase
Arm Type
Experimental
Arm Description
The investigators will stimulate using 2mA of direct current during 20 min during the extinction phase of the fear conditioning and extinction paradigm.
Arm Title
Active tDCS administered after extinction phase
Arm Type
Experimental
Arm Description
The investigators will stimulate using 2mA of direct current during 20 min after the extinction phase of the fear conditioning and extinction paradigm.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in skin conductance response (SCR) to the conditioned stimulus (CS+) versus the unconditioned stimulus (CS-) between tDCS conditions during extinction recall
Description
Higher skin conductance (microSiemens) indicates greater fear intensity.
Time Frame
Extinction Recall Phase (Day 2)
Title
Difference in frontomedial theta power (EEG) to the conditioned stimulus (CS+) versus the unconditioned stimulus (CS-) between tDCS conditions during extinction recall
Description
Greater reduction of frontomedial theta power (microvolts) indicates stronger extinction recall.
Time Frame
Extinction Recall Phase (Day 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peyton Miyares, BA
Phone
617-643-0850
Email
mghocdfearstudy@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, MPH, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peyton Miyares, BA
Phone
617-643-0850
Email
mghocdfearstudy@partners.org
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, MPH, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://mghocd.org/ocdfearstudy/
Description
Study website with more information
URL
https://redcap.link/ocdfearstudy_prescreen
Description
Eligibility Interest Form

Learn more about this trial

Transcranial Direct Current Stimulation Potentiation of Fear Extinction in OCD

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