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Cortical Stimulation to Treat Obsessive Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT04958096
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Andrew Moses Lee, MD, PhD, University of California, San Francisco

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Standard Therapeutic Deep Brain Stimulation Device: Cortical Stimulation for PFC Device: Cortical Stimulation for ACC Not Applicable

Detailed Description:

The investigators propose to perform electrophysiological investigations into the corticostriatal circuits mediating severe, refractory obsessive compulsive disorder (OCD) through chronic intracranial recordings and stimulation. This new study will utilize the Medtronic Percept, which is currently is approved for treating OCD under the Humanitarian Device Exemption (HDE).

In addition to their standard therapeutic DBS electrode(s) in the standard subcortical targets (anterior limb of the internal capsule- ALIC), patients enrolled in this study will have a second pair of leads placed in either the prefrontal cortex (PFC) or anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts for a total of 4 DBS leads.

After electrode implantations, patient will undergo 2 phases:

In phase 1 (day 1 - 12 months), the aim will be to identify a biomarker of OCD-related symptoms. Patient will undergo long-term monitoring of their OCD and related psychiatric symptoms along with recordings of cortical and subcortical local field potentials (LFPs). This phase will be conducted in both the outpatient office setting and patient's home environment.

In phase 2 (13 months - 2 years), the investigators will introduce cortical stimulation at either the PFC or ACC/cingulum in addition to stimulation at the ALIC. The investigators will continue to obtain brain recordings and ratings during this period of time to identify the impact of cortical stimulation on these signals.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 1, 2026
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Prefrontal Cortex (PFC)
The Prefrontal Cortex (PFC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the PFC.
 Device: Standard Therapeutic Deep Brain Stimulation
DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD

Device: Cortical 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
Other Name: PFC Stimulation
Experimental: Anterior Cingulate Cortex (ACC)
The Anterior Cingulate Cortex (ACC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the ACC.
 Device: Standard Therapeutic Deep Brain Stimulation
DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD

Device: Cortical 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
Other Name: OCD Cortical Stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months [ Time Frame: 12-24 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 Outcome Measures :
  1. Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months [ Time Frame: 12-24 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 Outcome Measures:
  1. Biomarker identification in Stage 1 [ Time Frame: 1-12 months ]
    The number of patients in whom we can identify a neural biomarker that accounts for a significant amount of variance in OCD symptom severity


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to give informed consent for the study
  • Age 22-75
  • Clinical diagnosis of OCD
  • Documented duration of OCD of at least 5 years
  • OCD rated as severe or extreme illness (YBOCs ≥ 28)
  • Has failed to improve following treatment with at least two selective serotonin reuptake inhibitors (SSRIs), clomipramine, and augmentation with antipsychotics
  • Has not responded to adequate trials of cognitive behavior therapy (exposure and response prevention)
  • Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient

Exclusion Criteria:

  • 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
  • Has a cognitive disorder or dementia
  • Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide
  • Inability to comply with study follow-up visits
  • Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
  • Allergies or known hypersensitivity to materials in the Activa systems (i.e. titanium, polyurethane, silicone, polyethermide, stainless steel).
  • Previous cranial ablative or deep brain stimulation surgery.
  • Patients may be excluded from enrollment due to a condition that, in the judgement of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04958096


Contacts
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Contact: Andrew M Lee, MD, PhD 415-502-5472 ocdresearch@ucsf.edu
Contact: Tenzin Norbu, BS 415-514-6489 ocdresearch@ucsf.edu

Locations
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United States, California
UCSF Nancy Friend Pritzker Psychiatry Building Recruiting
San Francisco, California, United States, 94107
Contact: Andrew M Lee, MD, PhD    415-502-5472    ocdresearch@ucsf.edu   
Contact: Tenzin Norbu, BS    415-514-6489    ocdresearch@ucsf.edu   
Principal Investigator: Andrew M Lee, MD, PhD         
Sub-Investigator: Tenzin Norbu, BS         
Sponsors and Collaborators
Andrew Moses Lee, MD, PhD
Investigators
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Principal Investigator: Andrew M Lee, MD, PhD University of California, San Francisco
More Information
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Publications:

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Responsible Party: Andrew Moses Lee, MD, PhD, Assistant Professor, Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04958096    
Other Study ID Numbers: 21-33743
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Andrew Moses Lee, MD, PhD, University of California, San Francisco:
OCD
Obsessive Compulsive Disorder
Obsessive thoughts
Compulsions
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders