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Clinical Trials/NCT04426773
NCT04426773CompletedNot Applicable

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

Shanghai Mental Health Center1 site in 1 country40 target enrollmentStarted: July 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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.

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

Time Frame: Up to 2 weeks

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.

EEG biomarkers as predictors of response to tDCS

Time Frame: baseline

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

Secondary Outcomes

  • Change in The Beck Depression Inventory(BDI)(Up to 3 months)
  • Change in Pittsburgh sleep quality index(PSQI)(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 The Beck Anxiety Inventory (BAI)(Up to 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhen Wang

vice-president

Shanghai Mental Health Center

Study Sites (1)

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