Electroencephalography (EEG) Predictors of Transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD)

NCT04426773 | Completed

• 1 other identifier: SMHC-OCD-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

transcranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

• Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  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.

  Up to 3 months

• Change in long-interval intracortical inhibition (LICI) and short interval intracortical inhibition (SICI) measured by TMS-EEG

  LICI and SICI are TMS-EEG paradigm to assess the extent of cortical inhibition. LICI and SICI will be measured using single and paired TMS pulses applied to the OFC. LICI and SICI will be compared between before and after treatment.

  Up to 2 weeks

• EEG biomarkers as predictors of response to tDCS

  LICI and SICI measured by TMS-EEG and resting state EEG will be performed to investigate predictors of response to tDCS in OCD patients.

  baseline

Secondary Outcomes (5)

• Change in Obsessive Compulsive Inventory-Revised(OCI-R)

  Up to 3 months

• Change in The Beck Depression Inventory(BDI)

  Up to 3 months

• Change in The Beck Anxiety Inventory (BAI)

  Up to 3 months

• Change in Pittsburgh sleep quality index(PSQI)

  Up to 3 months

• Change in Side-effect questionnaire

  Up to 3 months

Study Arms (1)

tDCS treatment

EXPERIMENTAL

Cathode transcranial direct current stimulation over the right OFC will be applied once a day, 5 days a week, for 2 weeks.

Device: High-Definition transcranial direct current stimulation

Interventions

High-Definition transcranial direct current stimulation DEVICE

The tDCS device will deliver a direct current of 1.5mA for 20 minutes. Cathode electrode will be localized in front of the 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).

tDCS treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zhen Wang, PhD,MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: April 30, 2025
• Study Completion: May 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)