RecruitingNot ApplicableNCT04958096

Cortical Stimulation to Treat Obsessive Compulsive Disorder

Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)


Sponsor

Andrew Moses Lee, MD, PhD

Enrollment

15 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a surgical brain stimulation approach — cortical stimulation (placing electrodes on the surface of the brain) — can reduce the symptoms of severe, treatment-resistant obsessive-compulsive disorder (OCD). This is for people who have tried multiple medications and therapy without adequate improvement. **You may be eligible if...** - You are between 22 and 75 years old - You have a clinical diagnosis of OCD lasting at least 5 years - Your OCD is rated severe or extreme (Y-BOCS score 28 or above) - You have not improved with at least two SSRI medications, clomipramine, antipsychotic augmentation, and intensive cognitive behavioral therapy - You have also not responded adequately to TMS if it was available to you **You may NOT be eligible if...** - Hoarding is your primary OCD symptom - You have a serious psychiatric condition like psychosis, bipolar disorder, or active substance abuse - You are pregnant - You have a neurological condition (like dementia or stroke) or a cognitive disorder - You are at imminent risk of suicide or have previously attempted suicide - You have had prior brain surgery (ablation or deep brain stimulation) - You have serious medical conditions that increase surgery risk (e.g., uncontrolled diabetes, severe hypertension, need for blood thinners) - You have an allergy to components of the device used in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStandard Therapeutic Deep Brain Stimulation

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

DEVICECortical Stimulation for PFC

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

DEVICECortical Stimulation for ACC

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


Locations(1)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, United States

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NCT04958096


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