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Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04806516
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : July 23, 2021
Sponsor:
Collaborators:
University of Pittsburgh
Brown University
Carnegie Mellon University
National Institute of Neurological Disorders and Stroke (NINDS)
Medtronic
Information provided by (Responsible Party):
Wayne Goodman MD, Baylor College of Medicine

Brief Summary:

This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors. OCD affects 2-3% of the US population, and is responsible for substantial functional impairment and increased risk of early death.

The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT) with exposure and response prevention and certain medications. About 30-40% of patients fail to respond and few experience complete symptom resolution. Up to 25% of patients have difficulty tolerating CBT and the risk of relapse after therapies remains large. For the most severe cases, neurosurgery (surgery in the brain), has long been the option of last resort.

In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system to use in subjects with intractable (hard to control) OCD. Deep brain stimulation (DBS) remains investigational for OCD patients and is not considered standard therapy. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed DBS may restore balance to dysfunctional brain circuitry implicated in OCD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for OCD treatment.

This current research protocol will focus on the completion of Phase II which will implant the RC+S system with ECoG paddles in 5 subjects.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Summit RC+S System with ECoG Paddles Other: One Month Blinded Discontinuation Period: Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: At the end of month 8 after DBS implant, all subjects will enter a one-month delayed onset withdrawal period in which the subject and Independent Evaluators are blinded to timing of discontinuation. See description below.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline.
Primary Purpose: Treatment
Official Title: Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable Obsessive-Compulsive Disorder (OCD) Phase II Using Summit RC+S System With ECoG Paddles
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Summit RC+S DBS Implant for OCD
All subjects will receive surgical implantation of RC+S DBS system with ECoG paddles
Device: Summit RC+S System with ECoG Paddles

Summit RC+S System with ECoG Paddles consists of:

  • Olympus RC+S implantable pulse generator (IPG), Model B35300R: 2 per subject x 5 subjects = 10 units
  • Extension Leads, Model 37087: 2 per subject X 5 subjects = 10 units
  • DBS Leads, Model 3387: 2 per subject X 5 subjects = 10 units
  • Patient Therapy Manager (PTM), Model 4NR009: 1 per subject x 5 subjects = 5 units
  • Recharge Therapy Manager (RTM), Model 97755: 1 per subject x 5 subjects = 5 units
  • Clinician Telemetry Module (CTM), Model 4NR011: 1 per subject x 5 subjects = 5 units
  • Research Lab Programmer (RLP), Model 4NR010: 1 unit
  • Research Software Development Kit (RDK), Model 4NR013: 2 units
  • Subdural Quadripolar Paddle Lead, Model 09130: 2 per subject x 5 subjects = 10 units
Other Names:
  • Deep Brain Stimulation System
  • DBS
  • Summit RC+S

Experimental: One Month Blinded Discontinuation Period
The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline
Other: One Month Blinded Discontinuation Period:
The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline.




Primary Outcome Measures :
  1. Percent of subjects that display biomarkers of OCD-related distress [ Time Frame: Month 6 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  2. Percent of subjects that display biomarkers of OCD-related distress [ Time Frame: Month 9 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  3. Percent of subjects that display biomarkers of OCD-related distress [ Time Frame: Month 12 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  4. Percent of subjects that display biomarkers of OCD-related distress [ Time Frame: Month 18 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with OCD-related distress during task exposure in clinic.

  5. Percent of subjects that display biomarkers of DBS-induced hypomania [ Time Frame: Month 6 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  6. Percent of subjects that display biomarkers of DBS-induced hypomania [ Time Frame: Month 9 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  7. Percent of subjects that display biomarkers of DBS-induced hypomania [ Time Frame: Month 12 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with DBS therapy during clinical visits.

  8. Percent of subjects that display biomarkers of DBS-induced hypomania [ Time Frame: Month 18 ]
    electrophysiological signals (deep brain local field potentials with electrocorticography) from the brain showing Cohen's kappa k > 0.40, chance corrected classification agreement with DBS therapy during clinical visits.


Secondary Outcome Measures :
  1. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity [ Time Frame: Baseline to 30 days ]
    Changes in the Yale-Brown Obsessive Compulsive Scale survey/questionnaire. This is measured after closed-loop stimulation and 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to any study specific procedures being performed
  2. Male or female between ages 21 and 70;
  3. At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;
  4. A primary diagnosis of OCD with Y-BOCS minimum score of 28;
  5. Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;
  6. Failed or could not tolerate an adequate trial of clomipramine;
  7. Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;
  8. Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;
  9. Stable psychotropic medical regimen for the month preceding surgery

Exclusion Criteria:

  1. Inability or refusal to give informed consent.
  2. Lifetime diagnosis of psychotic disorders such as schizophrenia;
  3. Alcohol or substance abuse/dependence within 6 months, excluding nicotine;
  4. Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments.
  5. Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate.
  6. Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months.
  7. Need for Diathermy
  8. Contraindications to MRI
  9. Contraindications to MEG
  10. Subject is determined to not be appropriate for this study based on the medical expertise of the investigator.

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): NCT04806516


Contacts
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Contact: Gregory Vogt 713-798-3876 gsvogt@bcm.edu
Contact: Luke Jumper 713-798-4113 jumper@bcm.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Brown University Active, not recruiting
Providence, Rhode Island, United States, 02912
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Gregory Vogt    713-798-4729    gsvogt@bcm.edu   
Contact: Luke Jumper    713-798-4113    jumper@bcm.edu   
Sub-Investigator: Sameer Sheth, MD         
Sub-Investigator: Ashwin Viswanathan, MD         
Sub-Investigator: Eric Storch, PhD         
Sub-Investigator: Junqian Xu, PhD         
Sub-Investigator: Meghan Robinson, PhD         
Sub-Investigator: Nithya Ramakrishnan, MS         
Sub-Investigator: Adriana Strutt, PhD         
Sub-Investigator: Jay Gavvala, MD         
Sponsors and Collaborators
Baylor College of Medicine
University of Pittsburgh
Brown University
Carnegie Mellon University
National Institute of Neurological Disorders and Stroke (NINDS)
Medtronic
Investigators
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Principal Investigator: Wayne Goodman, MD Baylor College of Medicine
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Responsible Party: Wayne Goodman MD, D. C. and Irene Ellwood Professor and Chair, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04806516    
Other Study ID Numbers: 49155
1UH3NS100549 ( U.S. NIH Grant/Contract )
49340 ( Other Grant/Funding Number: BCM ID )
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021

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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 Wayne Goodman MD, Baylor College of Medicine:
Deep Brain Stimulation (DBS)
Treatment Resistant OCD
Intractable OCD
Obsessive Compulsive Disorder (OCD)
Cognitive Behavior Therapy (CBT)
Exposure and Response Prevention (ERP)
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders