Obsessive Compulsive Disorder

Obsessive Compulsive Disorder

Deep Brain Stimulation (DBS) Therapy for Obsessive Compulsive Disorder (OCD)

Purpose of Study: This study plans to enroll up to 10 subjects who have been diagnosed with obsessive compulsive disorder (OCD). Once consented, the participant will undergo a Positron Emission Tomography/ Computerized Tomography (PET/CT) scan, Electroencephalography (EEG) with event-related potentials (ERP), and cognitive assessments prior to the DBS surgery. After surgery, the participant will repeat the PET/CT scan, EEG/ERP, and cognitive assessments every six months for two years. A total of five study visits is require for the study. Additional visits may be required if the PET/CT scan, EEG/ERP, and cognitive assessments cannot be scheduled or completed on the same day.


Eligibility Criteria: Patients who are candidates and are scheduled for deep brain stimulation (DBS) surgery for treatment-resistant OCD under FDA approval of HDE #H050003 will be approached and asked to participate in this research study. There is no additional eligibility criterion.


Status of Study: Open to Enrollment


Principal Investigator: Ali Rezai, MD


Contact: Thomas Geist
Phone: 614-293-0580
Email: Thomas.geist@osumc.edu



Sponsor: Ali Rezai, MD

Reclaim Deep Brain Stimulation (DBS) Therapy for Obsessive Compulsive Disorder

Purpose of Study: The Food and Drug Administration (FDA) gave approval of the Humanitarian Device Exemption (HDE) a Humanitarian use device for Medtronic Reclaim Therapy to Medtronic, Inc. (HDE# H050003). Medtronic Reclaim Deep Brain Stimulation (DBS) Therapy for Obsessive Compulsive Disorder (OCD) delivers electrical stimulation to areas in the brain to help control symptoms of treatment resistant OCD. The Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of a specific region of the brain (anterior limb of the internal capsule), in conjunction with OCD medications for treatment of chronic, severe, treatment resistant OCD in adult patients who have failed at least three selective serotonin reuptake inhibitor medications. DBS is used as an alternative to anterior capsulotomy (different type of surgery) that is indicated for this condition.


Principal Investigator: Ali Rezai, MD


Contact: Thomas Geist
Phone: 614-293-0580
Email: Thomas.geist@osumc.edu

Other Conditions

Other Conditions

Activa Dystonia Deep Brain Stimulation (DBS) Therapy

Purpose of Study: This protocol is for a Humanitarian Device Exemption (HDE). The Food and Drug Administration (FDA) gave approval of the HDE of a Humanitarian Use Device (HUD) for Medronic Activa® Dystonia Therapy on April 13, 2003, to Medtronic, Inc. (HDE Number: H020007) and it was approved at Ohio State University on May 10, 2010. Medtronic Activa® Deep Brain Stimulation Dystonia Therapy delivers electrical stimulation to internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis) in patients seven years of age or above who have completed at least one year of other treatment before being considered a surgical candidate.


Description of Study: This is not a research study; it is an FDA requirement for humanitarian use of the deep brain stimulation device in treating a rare disease, dystonia.


Eligibility Criteria: Patients seven years of age or older with chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis) who have completed at least one year of other treatment.


Principal Investigator: Ali Rezai, MD


Contact: Thomas Geist
Phone: 614-293-0580
Email: Thomas.geist@osumc.edu

RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Purpose of Study: To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use. Also, to evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice.


Description of Study: The study is a prospective, multicenter, global registry of Boston Scientific neurostimulation systems for pain. The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.


Eligibility Criteria: Men and women age 18 and older who are scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use, and have signed a valid, IRB/EC-approved informed consent form.


Status of Study: Recruiting


Principal Investigator: Milind Deogaonkar, MBBS


Contact: Thomas Geist
Phone: 614-293-0580
Email: Thomas.geist@osumc.edu


Sponsor: Boston Scientific Corporation

Reanimation in Tetraplegia

Purpose of Study: The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.


Description of Study: This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal cord injuries (motor and sensory complete neurologic injuries), who are more than one year post injury, and who are neurologically stable.


Eligibility Criteria: Men and women age 21 to 89 who are tetraplegic (C4- C6 ASIA A), 12 months post injury and neurologically stable, willing to comply with all follow-up evaluations at the specified times, able to provide informed consent prior to enrollment in the study, fluent in English, and have a caregiver willing to participate in the study who will provide care for the surgical site.


Status of Study: Recruiting


Principal Investigator: Ali Rezai, MD


Contact: Thomas Geist
Phone: 614-293-0580
Email: Thomas.geist@osumc.edu


Sponsor: Ali Rezai, MD

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