Clinical trial NCT04432246: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder (OCD)
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 30
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 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.

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

Primary outcomes:
measure: Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Up to 6 months
measure: EEG biomarkers as predictors of response to rTMS
timeFrame: baseline
Secondary outcomes:
measure: Change in The Beck Depression Inventory (BDI)
timeFrame: Up to 6 months
measure: Change in The Beck Anxiety Inventory (BAI)
timeFrame: Up to 6 months
measure: Change in The Perceived Stress Scale(PSS)
timeFrame: Up to 6 months
measure: Change in Pittsburgh sleep quality index(PSQI)
timeFrame: Up to 6 months
measure: Change in Obsessive Compulsive Inventory-Revised(OCI-R)
timeFrame: Up to 6 months
measure: Change in Side-effect questionnaire
timeFrame: Up to 6 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: