tDCS for Obsessive-Compulsive Disorder

N/A

Recruiting

Led By Joan Camprodon, MD, MPH, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up extinction recall phase (day 2)

Summary

This trial will investigate whether tDCS can help people with OCD to better control their fear.

Who is the study for?

This trial is for English-speaking adults with primary OCD causing moderate distress (Y-BOCS score ≥ 16). Participants should be comfortable using a computer. Excluded are those with significant head injuries, metal implants in the head/neck, pacemakers, pregnancy, epilepsy, recent substance abuse, history of mania or psychosis, resistance to multiple OCD treatments or use of benzodiazepines within two weeks.

What is being tested?

The study tests whether transcranial Direct Current Stimulation (tDCS) can help people with OCD overcome unwanted fear by altering brain activity. It compares active tDCS against sham (placebo) treatment to see if there's an improvement in managing fear.

What are the potential side effects?

Possible side effects from tDCS may include discomfort at the electrode site on the scalp, itching or tingling during stimulation, fatigue after treatment sessions and headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ extinction recall phase (day 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~extinction recall phase (day 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and extinction recall phase (day 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS administered during extinction phaseExperimental Treatment1 Intervention

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

Group II: Active tDCS administered before extinction phaseExperimental Treatment1 Intervention

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

Group III: Active tDCS administered after extinction phaseExperimental Treatment1 Intervention

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

Group IV: Sham tDCSPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active tDCS

2012

Completed Phase 1

~1190

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