A Randomized Clinical Trial of Transcranial Direct Current Stimulation(tDCS) Treatment for Drug-naïve Obsessive-Compulsive Disorder(OCD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obsessive-Compulsive Disorder
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This study will evaluate the possible therapeutic effects of Transcranial Direct Current Stimulation (tDCS) in drug-naïve obsessive-compulsive disorder (OCD) patients, and the underlying neural mechanism by magnetic resonance imaging (MRI),transcranial magnetic stimulation and electroencephalography (TMS-EEG).
Detailed Description
The purpose of this study is to examine the efficacy of tDCS over orbitofrontal cortex (OFC) in treatment of drug-naïve OCD patients. 60 drug-naïve OCD patients will be randomized into two groups (i.e. active or sham stimulation). tDCS stimulation will be performed once a day, five times a week, for two weeks. The investigators will assess symptom severity before and after two weeks of tDCS. Through the study, Yale-Brown Obsessive Compulsive Scale（Y-BOCS）, the Obsessive Compulsive Inventory-Revised (OCI-R), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), Perceived Stress Scale (PSS), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. The patients will also receive MRI scan and TMS-EEG.
Investigators
Zhen Wang
vice-president
Shanghai Mental Health Center
Eligibility Criteria
Inclusion Criteria
- •age: 18-50 years old;
- •DSM-5 criteria for OCD;
- •Y-BOCS total score \> or = 16, discontinued medication for at least 8 weeks before tDCS stimulation.
- •\>or＝9 years education
Exclusion Criteria
- •Any axis I psychiatric disorder comorbidity
- •The inability to receive tDCS because of metallic implants, or history of seizures，or 3.history of head injury, or history of neurosurgery.
- •Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
- •Any current significant medical condition.
- •serious suicide risk
Outcomes
Primary Outcomes
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score
Time Frame: Up to 3 months
It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.
Secondary Outcomes
- Change in Perceived Stress Scale(PSS)(Up to 3 months)
- Change in Side-effect questionnaire(Up to 3 months)
- Change in Obsessive Compulsive Inventory-Revised(OCI-R)(Up to 3 months)
- Change in Beck Depression Inventory(BDI)(Up to 3 months)
- Change in Pittsburgh sleep quality index(PSQI)(Up to 3 months)
- Change in Beck Anxiety Inventory (BAI)(Up to 3 months)