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Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder

Butler Hospital logo

Butler Hospital

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Other: ERP plus sham tDCS
Other: ERP plus tDCS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02329587
1R21MH104728-01 (U.S. NIH Grant/Contract)
1405-003

Details and patient eligibility

About

This study is investigating whether combining noninvasive brain stimulation with behavior therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment for OCD. This study will test whether a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS), can help ERP work better.

Enrollment

13 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Current primary OCD diagnosis and current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score of ≥16
  • 18-65 years of age
  • Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
  • Right-handed
  • No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry. Psychiatric medications will be limited to the following: serotonin reuptake inhibitors (SRI; including clomipramine), combination antidepressants (including bupropion and serotonin-norepinephrine reuptake inhibitors), buspirone, benzodiazepines, and/or stimulants
  • Naive to tDCS

Exclusion criteria

  • Active substance use disorder
  • Lifetime diagnosis of psychotic or bipolar mood disorder
  • Previous minimally adequate trial of ERP (e.g., at least 16 sessions including both therapist and self-directed exposure and response prevention)
  • Therapy outside the study protocol which has evidence for efficacy with OCD during the study intervention period
  • Active suicidal or homicidal ideation
  • Organic brain disease or injury
  • Any health problems that would interfere with study participation, including contraindications to tDCS (e.g., skin condition, mental implant in skull)
  • Women who are pregnant or breastfeeding. All women participants of child-bearing age are required to have a negative pregnancy test prior to treatment, and must use medically acceptable birth control during study participation. Medically acceptable birth control includes: established oral, injected, implanted, or vaginal ring hormonal contraception, an intrauterine device (IUD), two barrier contraception methods (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), or having a vasectomized partner
  • Use of anticonvulsant medications (including depakote, gabapentin, tegretol, dilantin, lamictal) and/or glutamate-acting agents (including n-acetylcysteine, riluzole, amantadine, memantine).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

13 participants in 2 patient groups

ERP plus tDCS
Experimental group
Description:
ERP plus anodal tDCS of right inferior frontal gyrus
Treatment:
Other: ERP plus tDCS
ERP plus sham tDCS
Active Comparator group
Description:
ERP plus sham tDCS of right inferior frontal gyrus
Treatment:
Other: ERP plus sham tDCS

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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