Transcranial Direct Current Stimulation (tDCS) in the Treatment of Drug-naïve Obsessive-compulsive Disorder(OCD)

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: high-definition transcranial direct current stimulation; Device: Sham tDCS

• Registration Number: NCT04086446
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-11
• Study Start: 2019-11-05
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tDCS	high-definition transcranial direct current stimulation	Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.
sham tDCS	Sham tDCS	The sham transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score	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 Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale(PSS)	Up to 3 months	It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.
Change in Side-effect questionnaire	Up to 3 months	It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of tDCS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Change in Obsessive Compulsive Inventory-Revised(OCI-R)	Up to 3 months	It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.
Change in Beck Depression Inventory(BDI)	Up to 3 months	It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.
Change in Pittsburgh sleep quality index(PSQI)	Up to 3 months	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Change in Beck Anxiety Inventory (BAI)	Up to 3 months	It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China