Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder
Primary Purpose
Obsessive Compulsive Disorder (OCD)
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous theta burst stimulation (cTBS)
Sponsored by

About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder (OCD)
Eligibility Criteria
Inclusion Criteria:
- age>18 years old;
- DSM-5 criteria for OCD;
- Y-BOCS total score > or = 16 ->or=9 yrs education
Exclusion Criteria:
- 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
Sites / Locations
- Shanghai Mental Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bilateral SMA
Arm Description
Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in The Beck Depression Inventory (BDI)
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 The Beck Anxiety Inventory (BAI)
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.
Change in The Perceived Stress Scale(PSS)
The Perceived Stress Scale (PSS) has 10 items to assess stress status within four weeks. Items are classified into five levels, from 0 (never) to 4 (very often). Total scores range from 0 to 40. The higher the total score, the stronger the level of stress the patient feels.
Change in Pittsburgh sleep quality index(PSQI)
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 Obsessive Compulsive Inventory-Revised(OCI-R)
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 Side-effect questionnaire
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 rTMS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Full Information
NCT ID
NCT04432246
First Posted
June 11, 2020
Last Updated
September 7, 2022
Sponsor
Shanghai Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT04432246
Brief Title
Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder
Official Title
Electroencephalography (EEG) Predictors of Repetitive Transcranial Magnetic Stimulation (rTMS) in Obsessive-Compulsive Disorder (OCD): A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.
Detailed Description
Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive neuromodulation technology, has been recommended for the treatment of patients with refractory OCD in multinational guidelines. However, due to the treatment setting and the patient's feature, nearly half of the patients have no significant changes after rTMS treatment.
In order to better predict the outcome of rTMS and improve the treatment efficiency, this project intends to look for markers that have a predictive effect at baseline or early treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before the symptoms change, thus it is possible to determine whether the patient has responded to the intervention.
In this project, the supplementary motor area (SMA) is selected as the stimulation target. The individual head magnetic resonance image positioning and navigation and rTMS compatible real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS single pulse stimulation and changes in neural networks before and after treatment. This is a preliminary exploration looking for effective predictive indicators of efficacy in EEG and the relationship between EEG and symptoms changes. In order to lay the foundation for further research and guide clinical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder (OCD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bilateral SMA
Arm Type
Experimental
Arm Description
Continuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Continuous theta burst stimulation (cTBS)
Intervention Description
50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
Primary Outcome Measure Information:
Title
Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
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.
Time Frame
Up to 6 months
Title
EEG biomarkers as predictors of response to rTMS
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Change in The Beck Depression Inventory (BDI)
Description
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.
Time Frame
Up to 6 months
Title
Change in The Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Up to 6 months
Title
Change in The Perceived Stress Scale(PSS)
Description
The Perceived Stress Scale (PSS) has 10 items to assess stress status within four weeks. Items are classified into five levels, from 0 (never) to 4 (very often). Total scores range from 0 to 40. The higher the total score, the stronger the level of stress the patient feels.
Time Frame
Up to 6 months
Title
Change in Pittsburgh sleep quality index(PSQI)
Description
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).
Time Frame
Up to 6 months
Title
Change in Obsessive Compulsive Inventory-Revised(OCI-R)
Description
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.
Time Frame
Up to 6 months
Title
Change in Side-effect questionnaire
Description
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 rTMS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>18 years old;
DSM-5 criteria for OCD;
Y-BOCS total score > or = 16 ->or=9 yrs education
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD,MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
12. IPD Sharing Statement
Learn more about this trial
Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder
We'll reach out to this number within 24 hrs