Development of Adaptive Deep Brain Stimulation for OCD (Phase Ib)
Obsessive-Compulsive Disorder
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Deep Brain Stimulation (DBS), Treatment Resistant OCD, Intractable OCD, Obsessive Compulsive Disorder (OCD), Cognitive Behavior Therapy (CBT), Exposure and Response Prevention (ERP)
Eligibility Criteria
Inclusion Criteria:
OCD DBS Subject Inclusion criteria:
- Signed informed consent prior to any study specific procedures being performed
- Male or female between ages 21 and 70;
- At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
- Y-BOCS minimum score of 28;
Failed an adequate trial of at least three of the following SSRIs:
Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
- Failed an adequate trial of clomipramine;
- Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
- Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
- Stable psychotropic medical regimen for the month preceding surgery
Non-Implanted Control Subject Inclusion criteria:
- Signed informed consent prior to any study specific procedures being performed
- Male or female between ages 21 and 70
Exclusion Criteria:
OCD DBS Subject Exclusion criteria:
- Inability or refusal to give informed consent.
- Lifetime diagnosis of psychotic disorders such as schizophrenia;
- Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
- Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
- Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
- Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
- Need for Diathermy
- Contraindications to MRI
Non-Implanted Control Subject Exclusion criteria:
- Inability or refusal to give informed consent.
- Lifetime diagnosis of mental illness
- A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
- Any neurological disorders (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
- Pregnant (confirmed by self-report for females of child bearing age)
- Contraindications to MRI
Sites / Locations
- University of Pittsburgh
- Brown University
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Summit RC+S DBS Implant for OCD
One Month Blinded Discontinuation Period
all subjects will receive surgical implantation of DBS system
The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline