Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.

Official Title
-----------------
Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study

Conditions
-----------------
Obsessive Compulsive Disorder (OCD)

Intervention / Treatment
-----------------
* Device: Transcranial magnetic stimulation
* Behavioral: Cognitive behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study: All subjects will be 18 - 65 years of age. Obsessive-compulsive disorder: Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive Y-BOCS total score > 16 Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits. Exclusion Criteria Subjects will be excluded from study participation if one of the following exclusion criteria applies: Subjects are unable or unwilling to give informed consent. No exclusion criteria for comorbid DSM diagnosis. Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to: Any condition likely to be associated with increased intracranial pressure. Space occupying brain lesion. Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study). History of stroke. Transient ischemic attack within two years. Cerebral aneurysm. Dementia. Mini Mental Status Exam (MMSE-2) score of <24. Parkinson's disease. Huntington's disease. Multiple sclerosis. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.8). Subjects with any of the following treatment histories: TMS treatment within 6 months prior to the screening visit. Lifetime history of treatment with Deep Brain Stimulation Use of any investigational drug or device within 4 weeks of the randomization visit. If participating in psychotherapy, must have been in stable treatment for at least 2 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the trial. Recent 2-month medication changes Contraindication to receive TMS: Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed. Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning. Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS and Cognitive Behavior Therapy<br> | Device: Transcranial magnetic stimulation<br> <br> Behavioral: Cognitive behavioral therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission Rate, as Measured by Y-BOCS | Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response, as Measured by Y-BOCS | Complete response is defined as a reduction of Y-BOCS score greater than 35%. | 6 weeks | 
| Partial Response Rate, as Measured by Y-BOCS | Partial response is defined as a reduction of greater than 25%. | 6 weeks | 
| Percentage of Adverse Events |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial magnetic stimulation (TMS), Cognitive behavioral therapy (CBT)