Parkinson's Disease Clinical Trial
Official title:
Characterizing the Specificity and Stability of Local Field Potentials in the Globus Pallidus Internus of Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
Deep brain stimulation for Parkinson's disease is a well established therapy. Current practice requires tedious adjustment of stimulation settings based on frequent patient assessments. Ultimately, the goal is to develop a system that can program itself using signals that are recorded directly from the brain on a continuous basis. Our previous work has identified abnormal electrical signals in the brain that are targeted for stimulation that can potentially be used to develop a self-programming system. In this study, the investigators will test the safety and utility of a novel adapted device that can not only deliver stimulation to the brain but also record brain signals in a patient that is implanted with a deep brain stimulation system. The purpose of this Phase I study is to understand the safety of the device as well as the relationship between these electrical signals measured from deep within the brain and Parkinson's symptoms and how these signals can be used to guide a self-programmed system. The study will entail implanting this special device (Activa PC+S) in place of the standard generator (Activa PC) and to compare clinical symptoms, recorded brain signals, and stimulation patterns during a one year period after implantation. Specifically, the investigators will use the Activa PC+S to record GPi (internal globus pallidus) local field potentials between and during programming visits, allowing the surgeon to better characterize a patient's disease. At the same time, the investigators will evaluate the safety of this new device.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Chart diagnosis of PD as the principal neurologic diagnosis with evidence of dopamine responsiveness. 2. Documented PD duration > 5 years. 3. Clinical indications for GPi DBS based on presence of motor fluctuations with troublesome dyskinesias despite best medical therapy. 4. Age = 21 years of age. 5. Able to give informed consent in accordance with institutional policies and participate in the 1-year follow-up, involving assessments and stimulator adjustments. 6. Willingness to have unexpected neurological or psychiatric symptoms shared with study clinicians. 7. Other medical conditions must be stable for at least 1 year, (conditions that require intermittent use of steroids or chemotherapy are excluded). Exclusion Criteria: 1. Tremor-dominant PD. 2. Significant neurocognitive impairment in memory domain suggestive of dementing process (based on MOCA and PD-CRS, described below). 3. Age > 75 years. 4. History of implant-related infection. 5. History of bleeding or immune-compromise. 6. Patient living greater than 100 miles from UCLA. 7. Suicide attempt in the last two years and/or presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview). 8. Alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response. 9. Current significant neurological conditions, including epilepsy, stroke, or history of serious head injury with loss of consciousness. 10. Uncontrolled medical condition including cardiovascular problems and diabetes. 11. Pregnant or planning to become pregnant 12. Uncontrolled chronic pain. 13. Preoperative use of warfarin or any blood thinning or antiplatelet agent or any patient with abnormally elevated preoperative coagulation profile (either PTT or PT/INR).. 14. Significant abnormality on preoperative structural brain MRI. 15. Contraindications to MRIs or the need for recurrent body MRIs. 16. High risk for surgery. 17. Has cardiac pacemaker/defibrillator, implanted medication pump, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulator. 18. Patient has had past cranial neurosurgery. 19. Patient unable to discontinue therapeutic diathermy. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nader Pouratian | Medtronic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | 12 months | No | |
Secondary | Change in Hoehn and Yahr Scale | 12 months | No | |
Secondary | Change in Parkinson's Disease Questionnaire (PDQ-39) | 12 months | No |
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