Clinical trial NCT04426773: Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)
Official title: Electroencephalography (EEG) Predictors of Response to Transcranial Direct Current Stimulation (tDCS) Treating Obsessive-Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: transcranial direct current stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to find Electroencephalogram (EEG) biomarkers to predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder.

Detailed description: The purpose of this study is to explore resting state electroencephalography and transcranial magnetic stimulation and electroencephalography (TMS-EEG) biomarkers that would predict transcranial direct current stimulation (tDCS) response in obsessive-compulsive disorder with cathode electrode targeting orbitofrontal cortex (OFC). 30 OCD patients will be recruited to this study and performed once a day, five times a week direct current stimulation treatment 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), Pittsburgh sleep quality index (PSQI)and side-effect questionnaire will be obtained by a trained investigator. Resting state electroencephalography and TMS-EEG testing will be conducted before and after tDCS treatment.

Eligibility criteria: Inclusion Criteria:

* age: 18-50 years old;
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16
* \>or＝9 years education

Exclusion Criteria:

* any additional current psychiatric comorbidity
* The inability to receive tDCS because of metallic implants, or history of seizures，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

Primary outcomes:
measure: Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Up to 3 months
measure: Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG
timeFrame: Up to 2 weeks
measure: EEG biomarkers as predictors of response to tDCS
timeFrame: baseline
Secondary outcomes:
measure: Change in Obsessive Compulsive Inventory-Revised(OCI-R)
timeFrame: Up to 3 months
measure: Change in The Beck Depression Inventory(BDI)
timeFrame: Up to 3 months
measure: Change in The Beck Anxiety Inventory (BAI)
timeFrame: Up to 3 months
measure: Change in Pittsburgh sleep quality index(PSQI)
timeFrame: Up to 3 months
measure: Change in Side-effect questionnaire
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: