Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-resistant obsessive compulsive disorder (OCD).

Detailed Description
-----------------
Despite advances in pharmacological and behavioral therapies for OCD, a substantial number of patients fail to improve significantly following years of conventional and experimental interventions. For some patients, stereotactic neurosurgery is the only promising option available. Although this procedure has relatively few side effects in the majority of OCD patients and may lead to enduring benefits, its effects on brain tissue and function are irreversible. Bilateral deep brain stimulation (DBS) is an adjustable and partially reversible procedure that may be a more effective treatment for patients with OCD. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory OCD. Participants receive DBS treatment for 30 months. Obsessive Compulsive scales, depression scales, neuropsychological evaluations, and surveys are used to assess participants. Participants are monitored for 2 years after DBS treatment.

Official Title
-----------------
Pilot Study of DBS for Treatment-Refractory OCD

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Procedure: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intractable, malignant, and treatment refractory OCD that has caused substantial suffering and a reduction in the patient's psychosocial functioning for > 5 years Poor prognosis without neurosurgical intervention Failed an adequate trial of clomipramine and at least two of the following selective serotonin reuptake inhibitors (SSRIs): fluoxetine, fluvoxamine, citalopram, sertraline, and paroxetine. Additionally, patients must have failed augmentation treatment with at least one of the above drugs for 1 month with at least two of the following: clonazepam, haloperidol, risperidone, olanzapine, and gabapentin. Willingness to undergo augmentation treatment with a low-dose neuroleptic if tics are present prior to surgery Failed an adequate trial of cognitive behavioral therapy/exposure response prevention while taking clomipramine and an SSRI Exclusion Criteria: Current or lifetime Axis I diagnosis that substantially complicates function, treatment, or the subject's ability to comply with study procedures, or may lead to serious adverse events such as overdose, attempted suicide, or other potentially threatening behaviors Diagnosis and/or treatment for depression within the past year. Patients with a more distant history of depression will not be excluded. Previous neurosurgical procedure or AXIS III diagnosis of brain pathology Implants that contain electrical circuitry, generate electrical signals, and/or have metal parts Nonremovable body jewelry Anticoagulants or other medications that would put patients at risk for surgery-related complications Diathermy for physical therapy Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>Participants receive deep brain stimulation treatment for 30 months. | Procedure: Deep Brain Stimulation<br>* Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey |  | Measured pre- and post-intervention |