OCD Biomarker Survey Employing sEEG and Stimulation: The OBSESS Trial (OBSESS)

• ClinicalTrials.gov Identifier: NCT05422469
• Recruitment Status: Not yet recruiting
• First Posted: June 16, 2022
• Last Update Posted: April 18, 2023
• Sponsor: Baylor College of Medicine
• Collaborators: Brown University; Carnegie Mellon University; Duke University; William Marsh Rice University; University of Washington; Mclean Hospital
• Information provided by (Responsible Party): Sameer Sheth, Baylor College of Medicine

Study Description

Brief Summary:

Obsessive-compulsive disorder (OCD) has a lifetime prevalence of 2-3% and is a major cause of global disability.

Deep brain stimulation (DBS) is an effective treatment for patients with severe, treatment-resistant forms, but access to and utilization of this therapy remains minimal despite FDA approval via HDE. The investigator's goal is to determine the neurophysiological basis of key symptom domains underlying OCD and derive individual-specific stimulation parameters to improve consistency of outcomes and facilitate outpatient therapy delivery. To do so, the investigators take advantage of key novel DBS device features, including imaging-based "inverse solutions" to determine optimal stimulation parameters, as well as on-device neural recordings that will guide therapy delivery.

The investigators will recruit patients with OCD meeting established criteria for surgical evaluation. Each will be implanted with permanent DBS leads and temporary stereo-EEG (sEEG) electrodes. In the inpatient unit, the investigators will first demonstrate how these DBS leads anatomically engage these hub-like DBS target regions and physiologically affect pre-frontal networks. In the outpatient phase, the investigators implement the inverse solutions parameters in a double-blinded head-to-head trial to test whether these personalized parameter sets can reduce symptoms in the domain-specific manner in which the personalized parameters were designed. Doing so would be the first demonstration of data-derived, individual specific DBS programming. Demonstrating clinical outcomes comparable to those achieved by expert programmers but with software-generated stimulation parameters will help demystify the programming process and increase accessibility to this therapy. Finally, and critically, patients will provide chronic on-device recordings labeled with behavioral data from wearables and portables. These naturalistic data will transform the investigator's understanding of the physiological signatures of OCD and provide biomarkers of symptom severity, therapeutic response, and potentially side effects, which will guide future therapy.

Condition or disease	Intervention/treatment	Phase
Obsessive-Compulsive Disorder (OCD)	Device: Medtronic Percept RC neurostimulator	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: OCD Biomarker Survey Employing sEEG and Stimulation: The OBSESS Trial
• Estimated Study Start Date: January 2024
• Estimated Primary Completion Date: January 2029
• Estimated Study Completion Date: January 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: Medtronic Percept RC neurostimulator	Device: Medtronic Percept RC neurostimulator; Medtronic SenSight directional DBS leads and implanted pulse generators (IPGs) will be implanted

Outcome Measures

Primary Outcome Measures :

1. Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score [ Time Frame: Through study completion, an average of 14 months ]
   Severity of depression symptoms. Changes in the Yale-Brown Obsessive Compulsive Scale survey/questionnaire. YBOCS is an assessment to rate symptoms of OCD on a scale of 0-50 (with a higher number indicating a more severe outcome ratings of OCD and 0 indicated no symptoms of OCD).
2. Change in Hamilton Depression Inventory (HAM-D) Score [ Time Frame: Through study completion, an average of 14 months ]
   Severity of depression symptoms. Changes in the Hamilton Depression Inventory (HAM-D) score. HAM-D is an assessment to rate symptoms of depression on a scale of 0-52 (with a higher number indicating a more severe outcome ratings of depression and 0 indicated no symptoms of depression).

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Principal diagnosis of OCD, confirmed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 28;
• Men and women (non-pregnant) between ages 21 and 70;
• The patient has had at least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
• Comorbid signs and symptoms of depression deemed secondary (based on history and clinical judgment) to OCD with minimum score of 16 on the HAM-D;
• Has failed an adequate trial (≥3 months at the maximum tolerated therapeutic dose) of at least three of the following SSRIs: fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
• Has failed an adequate trial (150 - 250 mg) of clomipramine;
• Has failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; zisprasidone; aripiprazole;
• Must have failed an adequate trial of CBT for OCD; defined as ≥20 sessions of documented exposure and response prevention (ERP) by an expert therapist;
• Stable psychotropic medical regimen for the month preceding surgery;
• Able to provide fully informed, written consent;
• A family member or significant other is available and willing to communicate with the research team if the patient's clinical status worsens (e.g., develops hypomania), and if necessary to accompany patients to study visits.

Exclusion Criteria:

• Has a lifetime diagnosis of psychotic disorder such as schizophrenia;
• Comorbid Tourette's Disorder is exclusionary if the tic symptoms are the same presenting problem or at equivalent severity/impairment with OCD symptoms;
• Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
• Deemed at high risk of suicidal behavior or impulsivity;
• MMSE score < 24;
• Premorbid IQ estimate < 85;
• Any neurological or medical condition/disorder that makes the patient, in the opinion of the surgeon, a poor candidate to undergo the intended surgical procedures of the study;
• Pregnant or plans to become pregnant in the next 24 months;
• Need for diathermy;
• Anticipated need for periodic MRI scans;
• Any psychiatric disorder that, in the opinion of the Scientific Steering Group, may interfere with the candidate's ability to participate in study activities.

Contacts and Locations

Contacts

Contact: Sameer Sheth, MD, PhD; 713-798-5060; sameer.sheth@bcm.edu

Locations

United States, Rhode Island

Brown University

Providence, Rhode Island, United States, 02912

Contact: Wael Asaad wael_asaad@brown.edu

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Contact: Sameer Sheth, MD, PhD 713-798-5060 sameer.sheth@bcm.edu

Sponsors and Collaborators

Baylor College of Medicine

Brown University

Carnegie Mellon University

Duke University

William Marsh Rice University

University of Washington

Mclean Hospital

More Information

• Responsible Party: Sameer Sheth, Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT05422469
• Other Study ID Numbers: RFA-NS-21-024
• First Posted: June 16, 2022
• Last Update Posted: April 18, 2023
• Last Verified: April 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sameer Sheth, Baylor College of Medicine:

Deep Brain Stimulation (DBS); Treatment Resistant OCD; Intractable OCD

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder; Mental Disorders; Anxiety Disorders