Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 22 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | February 2020 |
| Contact: | Carson R Reider, PhD |
| Email: | carson.reider@osumc.edu |
| Phone: | 614-292-9274 |
Concurrent Deep Brain Stimulation (DBS) Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
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. The data collected and LFP markers identified will serve as guidelines for
future stimulation predicted programming.
(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. The data collected and LFP markers identified will serve as guidelines for
future stimulation predicted programming.
The goals of this study are to evaluate local field potentials (LFP) and associated beta,
gamma and other band oscillations and their correlation with disease pathophysiology and
clinical status of the patients, and to potentially determine a more objective biomarker of
response to deep brain stimulation (DBS) treatment. This study aims to find evidence that
changes in the power and coherence of the beta and gamma bands can be consistently linked to
DBS adjustment and associated clinical effects. This approach can be of significant
potential benefit to provide a foundation for closed loop DBS therapy in patients with
continuous DBS adjustments.
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.
gamma and other band oscillations and their correlation with disease pathophysiology and
clinical status of the patients, and to potentially determine a more objective biomarker of
response to deep brain stimulation (DBS) treatment. This study aims to find evidence that
changes in the power and coherence of the beta and gamma bands can be consistently linked to
DBS adjustment and associated clinical effects. This approach can be of significant
potential benefit to provide a foundation for closed loop DBS therapy in patients with
continuous DBS adjustments.
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.
Inclusion Criteria:
- Participants who are candidates for DBS surgery.
- 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:
- Significant cognitive impairment or dementia.
- 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.
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Ali Rezai, MD
Phone: 614-293-9274
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