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Development of Adaptive Deep Brain Stimulation for OCD

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ClinicalTrials.gov Identifier: NCT03457675
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : January 17, 2019
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/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 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 deep brain stimulation 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.

Phase Ia is to gather data to eventually develop a prototype adaptive DBS system for intractable OCD that uses signals from the brain to automatically adjust the DBS stimulation factors. The overall goal is to improve symptom management and reduce stimulation-induced behavioral side effects.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Activa PC+S DBS implant for OCD Other: One Month Blinded Discontinuation Period Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 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 OCD: Phase Ia Using Activa PC+S
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Activa PC+S DBS implant for OCD
all subjects will receive surgical implantation of DBS system
Device: Activa PC+S DBS implant for OCD

DBS system consists of the Activa PC+S Neurostimulation System:

Model 37604 Activa PC+S Neurostimulator Model 37087 DBS Extension Model 37441 Patient Programmer Model 8181 Sensing Programmer Model 8180 Sensing Programmer Software Nexus D2/D3 System Nexus D2/D3 Application Programming Interface (API) Dow Corning Medical Adhesive, Medtronic Part #080118 Model 3387/3389 DBS Leads Model 37022 External Neurostimulator Model 8840 N'Vision Clinician Programmer Model 8870 Application Card Model 37642 Patient Programmer Model 37092 Patient Programmer Antenna

Other Names:
  • Deep Brain Stimulation System
  • DBS
  • Activa PC+S System

Experimental: One Month Blinded Discontinuation Period
all subjects will enter a one-month blinded discontinuation period to confirm clinical benefit at the end of Month 8.
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 scalp electroencephalography) 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 scalp electroencephalography) 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 scalp electroencephalography) 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 scalp electroencephalography) 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 scalp electroencephalography) 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 scalp electroencephalography) 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 scalp electroencephalography) 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 scalp electroencephalography) 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 ]
    measured after closed-loop stimulation



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

Inclusion Criteria:

  • OCD DBS Subject 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. 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 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
  • Non-Implanted Control Subject Inclusion criteria:

    1. Signed informed consent prior to any study specific procedures being performed
    2. Male or female between ages 21 and 70
  • Implanted ET Subject Inclusion criteria:

    1. Signed informed consent prior to any study specific procedures being performed
    2. Male or female between ages 21 and 70
    3. Diagnosed with Essential Tremor (ET) chronically, EXCLUDING head tremor, and implanted with DBS

Exclusion Criteria:

  • OCD DBS Subject 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
  • Non-Implanted Control Subject Exclusion criteria:

    1. Inability or refusal to give informed consent.
    2. Lifetime diagnosis of mental illness
    3. A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
    4. Any neurological disorders (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
    5. Pregnant (confirmed by self-report for females of child bearing age)
    6. Contraindications to MRI
  • Implanted ET Subject Exclusion criteria

    1. ET subjects (with DBS implanted), WITH head tremor, may exacerbate artifact, therefore they will be excluded.
    2. Inability or refusal to give informed consent.
    3. Lifetime diagnosis of mental illness
    4. A score of 8 or greater on part B of the Florida Obsessive Compulsive Inventory
    5. Any other neurological disorder other than ET (i.e., MS, Parkinson's Disease, seizure disorders, etc.) or evidence of brain abnormalities/injury, such as tumor, stroke, or traumatic brain injury
    6. Contraindications to MRI

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): NCT03457675


Contacts
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Contact: Gregory Vogt 713-798-4729 gsvogt@bcm.edu
Contact: Clarissa Aguilar 713-798-3080 clarissa.aguilar@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: Clarissa Aguilar    (713) 798-3080    clarissa.aguilar@bcm.edu   
Principal Investigator: Wayne K Goodman, MD         
Sub-Investigator: Ashwin Viswanathan, MD         
Sub-Investigator: Sameer Sheth, MD         
Sub-Investigator: Eric Storch, PhD         
Sub-Investigator: Elizabeth McIngvale, PhD         
Sub-Investigator: Stefan Ursu, MD         
Sub-Investigator: Joohi Jimenez-Shahed, MD         
Sub-Investigator: Adriana Strutt, PhD         
Sub-Investigator: Ramiro Salas, PhD         
Sub-Investigator: Meghan Robinson, PhD         
Sub-Investigator: Raymond Cho, MD         
Sub-Investigator: Nithya Ramakrishnan, MS         
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, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03457675     History of Changes
Other Study ID Numbers: H40255
1UH3NS100549 ( U.S. NIH Grant/Contract )
49340 ( Other Grant/Funding Number: BCM ID )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders