Parkinson Disease Clinical Trial
Official title:
Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Intraoperative Studies)
Verified date | March 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to measure neural activity during deep brain stimulation (DBS). There are two types of neural activity that we will record from DBS electrodes during this study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We will measure the effects of varying stimulation parameters on both the neural activity and changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease (PD). Correlating neural activity characteristics with changes in symptoms will improve our understanding of the mechanisms of action of DBS. This intraoperative study will specifically compare our ability to record neural activity using circuitry developed at Duke for this purpose [Kent et al, 2015] to a new, implanted pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the efficacy of the implantable RC+S IPG in PD patients once this device is available and approved for this trial.
Status | Completed |
Enrollment | 5 |
Est. completion date | March 26, 2019 |
Est. primary completion date | March 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Parkinson's disease (PD) patients who are scheduled to already undergo the planned deep brain electrode placement for treatment of their movement disorder at Duke University Medical Center. - Able to understand the study and consent form, and interested in proceeding with research during the invasive brain surgery to receive a DBS system for treatment of PD. Exclusion Criteria: - Inability to execute the motor tasks during the study. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Dennis Turner, M.D. | National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Recorded Evoked Neural Signals From Deep Brain Stimulation (DBS) Electrodes During DBS for Parkinson's Disease. | Measured by the ability to record neural activity through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation. | End of procedure, approximately 45 minutes | |
Secondary | Number of Participants With Recorded DBS Local Evoked Potentials (DLEPs). | Measured by the ability to record DLEPs (changes in local electric field in response to DBS stimulation) through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation. The DLEP recordings will be serially averaged with stimulus-triggering to remove random noise while preserving the evoked response. | End of procedure, approximately 45 minutes | |
Secondary | Number of Participants With Recorded Spontaneous, Local Field Potentials (LFPs). | Measured by the ability to record LFPs (electrical activity in the local region of the DBS electrode) through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation. | End of procedure, approximately 45 minutes |
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