Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
NCT ID: NCT03630302
Last Updated: 2021-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
10 participants
OBSERVATIONAL
2018-07-12
2020-01-31
Brief Summary
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Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can predict the optimal stimulation parameters.
Aim-2: Compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.
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Detailed Description
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Approximately 15 subjects will be enrolled in this clinical investigation. The clinical investigation will be conducted at 2 centers in the USA.
Subjects participating in this clinical investigation will monitored during DBS implant procedure and programming. The expected duration of enrollment is 8 months. The total duration of the clinical investigation is expected to be 1 year.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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DBS
Deep Brain Stimulation
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
* Diagnosis of idiopathic Parkinson's disease, and DBS consensus team review supporting the placement of STN DBS.
Exclusion Criteria
* In the Investigator's opinion the subject unable to tolerate multiple programming sessions within a single setting;
* Subject unable to comply with the follow-up schedule
18 Years
70 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
University of Houston
OTHER
Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRD_931 INVENT
Identifier Type: -
Identifier Source: org_study_id
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