Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable OCD: Phase Ia Using Activa PC+S

Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: t
View:

• OCD DBS Subject Inclusion criteria:

‣ Signed informed consent prior to any study specific procedures being performed

⁃ Male or female between ages 21 and 70;

⁃ At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning;

⁃ Y-BOCS minimum score of 28;

⁃ Failed an adequate trial of at least three of the following SSRIs:

‣ Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine;

⁃ Failed an adequate trial of clomipramine;

⁃ Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol; risperidone; quetiapine; ziprasidone; aripiprazole;

⁃ Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist;

⁃ Stable psychotropic medical regimen for the month preceding surgery

• Non-Implanted Control Subject Inclusion criteria:

‣ Signed informed consent prior to any study specific procedures being performed

⁃ Male or female between ages 21 and 70

• Implanted ET Subject Inclusion criteria:

‣ Signed informed consent prior to any study specific procedures being performed

⁃ Male or female between ages 21 and 70

⁃ Diagnosed with Essential Tremor (ET) chronically, EXCLUDING head tremor, and implanted with DBS

Locations
United States
Pennsylvania
University of Pittsburgh
Pittsburgh
Rhode Island
Brown University
Providence
Texas
Baylor College of Medicine
Houston
Time Frame
Start Date: 2018-07-11
Completion Date: 2025-06
Participants
Target number of participants: 2
Treatments
Experimental: Activa PC+S DBS implant for OCD
all subjects will receive surgical implantation of DBS 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.
Sponsors
Collaborators: Brown University, Medtronic, University of Pittsburgh, Carnegie Mellon University, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov