Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device

Withdrawn before enrolling · Not applicable

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT02731365

Run by

Vibhor Krishna

People needed

0

Starts

2015-02-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-17

Who can join

Age: 22 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Ohio State University Wexner Medical Center - Center for Neuromodulation — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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