Cortical Stimulation to Treat Obsessive Compulsive Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorAndrew Moses Lee, MD, PhD

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Standard Therapeutic Deep Brain Stimulation

    Device

    DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD

  • Cortical Stimulation for PFC

    Device

    Patients 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

    Device

    Patients 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

15 Participants
are divided into 2 treatment groups
Group A: Prefrontal Cortex (PFC)Experimental treatment 2 interventions
Group B: Anterior Cingulate Cortex (ACC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12-24 months

Secondary outcomes

1

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.

Time frame
12-24 months

Other outcomes

1

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

Time frame
1-12 months

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