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| Name | Class |
|---|---|
| Swedish Medical Center | OTHER |
| Medtronic | INDUSTRY |
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The purpose of this study is to record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator. The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy.
The Activa PC+S system will be implanted and programmed under the same clinical procedures and standard of care as the Activa PC system. After implantation and standard clinical programming, participants in our research study will be asked to return for additional research visits where the recording sub-circuit of the device will be activated and local field potentials (LFP) will be recorded in the device and transmitted through telemetry to a base station for storage and future analysis. The sensing, or recording, sub-circuit will be disabled, non-invasively, at the end of each research visit to minimize impact to battery life of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activa PC+S | Experimental | Specific features of LFP recorded from the deep brain nuclei will be examined for possible correlation with different natural behaviors, such as movement, walking, or speech. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activa PC+S | Device | Subjects will undergo placement of bilateral standard Deep Brain Stimulation (DBS) electrodes (Medtronic model 3387/3389) and implantation of the Activa PC+S, a modified impulse generator (IPG) for DBS with the added technology of neural signal recording. |
| Measure | Description | Time Frame |
|---|---|---|
| Specific features of local field potentials recorded from the deep brain nuclei during different natural behaviors, such as movement, walking, or speech. | The broadband time domain neural signal across all bipolar pairs will be recorded in series while subjects perform structured behavioral tasks. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Hanrahan, PhD | Contact | 720-974-4093 | shanrahan@thecni.org |
| Name | Affiliation | Role |
|---|---|---|
| Adam O Hebb, MD | Colorado Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Neurological Institute | Recruiting | Englewood | Colorado | 80113 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |