Obsessive Compulsive Disorder (OCD)
Conditions
Brief summary
This study will evaluate the decision-making ability and therapeutic effects of accelerated Transcranial Direct Current Stimulation (tDCS) as adjunct to pharmacotherapy in obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by EEG and MRI.
Detailed description
The purpose of this study is to examine the decision-making ability and clinical efficacy of accelerated tDCS over orbitofrontal cortex (OFC) as adjunct to pharmacotherapy in treatment of OCD patients.60 OCD patients on stable medication will be randomized into two groups (i.e. active or sham stimulation). Accelerated tDCS stimulation will be performed four times a day, five times a week, for one week. Iowa Gambling Task will be conducted at the baseline, after the one week tDCS and at the 1-month follow-up to evaluate the decision-making ability of OCD patients.The investigators will assess symptom severity before and after one week of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, Clinical Global Impression(CGI), the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory-II (BDI-II), the Beck Anxiety Inventory (BAI), Childhood Trauma Questionnair(CTQ), side-effect questionnaire and other scales will be obtained by a trained investigator.The patients will also receive magnetic resonance imaging (MRI) scan, electroencephalography (EEG).
Interventions
The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode electrode will be localized in front of the right OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8)
DEVICESham tDCS
To demonstrate the same stimulation sensation as under real conditions, only 40 seconds of real stimulation (2mA) are given at the beginning of the treatment. In the remaining 20 minutes, only about 15ms of short current pulses of 110uA occur every 550ms.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-60 years old, Han ethnicity, right-handed 2. DSM-5 criteria for OCD; 3. Y-BOCS total score ≥16, receiving stable medication for at least 4 weeks before tDCS stimulation. 4. Years of education ≥9.
Exclusion criteria
1. Any axis I psychiatric disorder comorbidity 2. Severe obsessive-compulsive symptoms that render the patient unable to complete required assessment procedures. 3. Previous treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or transcranial direct current stimulation (tDCS). 4. Severe somatic diseases or any physical conditions that may induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, etc. 5. History of neurological disorders (e.g., epilepsy, cerebrovascular accidents) or traumatic brain injury/brain surgery. 6. Implantation of intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, or other internal medical devices. 7. Women who are pregnant or planning to become pregnant in the near future. 8. Serious suicide risks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale(Y-BOCS) | Up to 5 weeks | The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Beck Depression Inventory-II(BDI-II) | Up to 5 weeks | It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression. |
| The Beck Anxiety Inventory (BAI) | Up to 5 weeks | It is a 21-item self-report inventory that is used for measuring the severity of anxiety. |
| Side-effect questionnaire | Up to 5 weeks | It consists of ten commonly-reported side effects as well as an other category that allows participants to describe experiences/sensations not otherwise covered to rate the intensity of side effects. |
Countries
China
Contacts
Primary ContactQing Zhao, PhD,MD
Backup ContactQing Wang, PhD
Outcome results
None listed