Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder

NCT04432246 | Completed

• 1 other identifier: SMHC-OCD-007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.

Conditions

Obsessive Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (2)

• 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 6 months

• EEG biomarkers as predictors of response to rTMS

  TMS-EEG and resting state EEG will be performed to investigate predictors of response to rTMS in OCD patients. The α, β and δ band power in resting state in each brain area of OCD patients will be recorded and analyzed. Also, in TMS treatment, event related potentials (ERPs) including motor evoked potentials (MEPs) amplitude, I waves, α band power and β band power will be analyzed.

  baseline

Secondary Outcomes (6)

• Change in The Beck Depression Inventory (BDI)

  Up to 6 months

• Change in The Beck Anxiety Inventory (BAI)

  Up to 6 months

• Change in The Perceived Stress Scale(PSS)

  Up to 6 months

• Change in Pittsburgh sleep quality index(PSQI)

  Up to 6 months

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

  Up to 6 months

Study Arms (1)

bilateral SMA

EXPERIMENTAL

Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.

Device: Continuous theta burst stimulation (cTBS)

Interventions

Continuous theta burst stimulation (cTBS) DEVICE

50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

bilateral SMA

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder serious suicide risk;
• the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
• any major medical disease;
• pregnancy or nursing of an infant;
• participation in current clinical study;
• current use of any investigational drug;
• TMS/DBS treatment at any point in their lifetime;
• history of long-time use of benzodiazepines

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: Director

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: June 11, 2020
• Primary Completion: July 28, 2022
• Study Completion: August 30, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

CN (1)