About this trial
The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. While treating OCD with standard deep brain stimulation (DBS) therapy, the investigators will also monitor the activity of the anterior cingulate and prefrontal cortex, a region known be involved with OCD, decision making, and emotion regulation, and the investigators will identify abnormal activity corresponding to the severity of a patient's OCD. The investigators will also investigate whether it is possible for stimulation delivered to these parts of the brain can improve OCD symptoms. These investigations have the potential to aid in the development of improved forms of DBS that can better target abnormal OCD brain signatures in the future.
The investigators will implant a cortical electrode in addition to the ALIC DBS electrode and connect these to an implantable pulse generator that care store field potential data (Medtronic Percept). The decision whether the lead is placed in the prefrontal or cingulate cortex bilaterally will be based upon considerations of the surgical risks for a particular patient based upon their anatomy and the required surgical approach.
At multiple time points post-implantation up to 2 years, in our clinic or patient's homes, cortical and subcortical signals will be recorded. Data will be collected while patient are resting or engaged in symptom provocation tasks, emotional/cognitive tasks while cortical stimulation is on and off. In addition to brain signal recordings, symptoms will be assessed using validated questionnaires and tasks to allow identification of neurophysiological correlates of OCD symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to give informed consent for the study
Age 22-75
Clinical diagnosis of OCD
Documented duration of OCD of at least 5 years
Disqualifiers
Has hoarding as a primary subclassification of OCD according to DSM-4
Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
Is pregnant
Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
Trial design
Parallel
Treatments tested in this trial
Standard Therapeutic Deep Brain Stimulation
DeviceDBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
Cortical Stimulation for PFC
DevicePatients enrolled in this study will have a second pair of leads placed in the prefrontal cortex (PFC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
Cortical Stimulation for ACC
DevicePatients enrolled in this study will have a second pair of leads placed in the anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
Treatment groups
Trial outcomes
Primary outcomes
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months
The Y-BOCS is an OCD symptom scale used for identifying current OCD symptom severity. The score ranges from 0-40, with higher scores indicating more severe OCD symptoms. The change in Y-BOCS score from 12 months to 24 months will be reported.
Secondary outcomes
Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months
Effect size of cortical stim + ALIC DBS compared to ALIC DBS (mean difference in Montgomery Asberg Depression Rating Scale (MADRS) score at 12 months and 24 months. Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.
Other outcomes
Biomarker identification in Stage 1
The number of patients in whom we can identify a neural biomarker that accounts for a significant amount of variance in OCD symptom severity
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrew Moses Lee, MD, PhD
Lead sponsor
University of California, San Francisco
Sponsor institution