Clinical trial NCT02731365: Concurrent DBS Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
Official title: Concurrent Deep Brain Stimulation (DBS) Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify and record LFP
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - Center for Neuromodulation
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ali Rezai, MD
role: PRINCIPAL_INVESTIGATOR
References: