Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
NCT ID: NCT02731365
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-02-28
2016-11-30
Brief Summary
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Detailed Description
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This study will use a novel bi-directional neural interface system that can chronically and simultaneously record, sense, process and telemeter LFP signals from DBS electrode (Rouse et al. 2011) to study the stability and subsequent change to LFP linked to the clinical state relevant to the present disorder, and DBS stimulation at rest and during motor and cognitive tasks. This investigation will be conducted at the Ohio State University.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DBS LFP Activa PC+S
The study aims at testing a slightly modified device (battery) that is similar to the approved system that has the potential of offering future patients a closed loop system with automatic adjustments of stimulation. The purpose of this clinical study is to allow the investigation of local field potential (LFP) signals in patients treated with DBS of the STN. This study will identify common LFP biomarkers observed as a function of disease symptoms, medication effect, fluctuations in disease, and changes resulting from adjustments from current standard practices of DBS programming.
Activa PC+S
The Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer.
Interventions
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Activa PC+S
The Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer.
Eligibility Criteria
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Inclusion Criteria
* Age 22-90 years of age
* Participant is willing to comply with all follow-up evaluations at the specified study time points.
* Participant is able to provide informed consent prior to enrollment in the study.
* The participant is fluent in English.
Exclusion Criteria
* Uncontrolled depression, anxiety or other mood disorder.
* Medical contraindications for general anesthesia, craniotomy, or DBS surgery.
* Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
* Condition requiring diathermy after DBS implantation.
* Subjects with any type of destruction and/or damage to the STN as determined by brain imaging.
* Co-morbid conditions that would interfere with study activities or response to treatment, which may include:
* Life expectancy \< 3 years
* Severe Chronic pulmonary disease
* Intractable seizure disorders
* Local, systemic acute or chronic infectious illness
* Life threatening cardiac arrhythmias
* Severe collagen vascular disorder
* Kidney failure or other major organ systems failures
* History of a neurological ablation procedure.
* Labeled contraindication for MRI.
* History of hemorrhagic stroke.
* History of HIV infection or ongoing chronic infection (such as tuberculosis). Participation in another FDA device or medication trial that would interfere with the current study.
22 Years
90 Years
ALL
No
Sponsors
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Vibhor Krishna
OTHER
Responsible Party
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Vibhor Krishna
Assistant Professor
Principal Investigators
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Ali Rezai, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Wexner Medical Center - Center for Neuromodulation
Columbus, Ohio, United States
Countries
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Other Identifiers
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2014H0423
Identifier Type: -
Identifier Source: org_study_id