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

Parkinson's Disease Clinical Trial

Official title:

Concurrent Deep Brain Stimulation (DBS) Local Field Potential Analysis and Stimulation in a Closed-Loop Neuromodulation Device

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02731365
• Other study ID #: 2014H0423
• Status: Withdrawn
• Phase: N/A
• First received: October 13, 2015
• Last updated: November 16, 2016
• Start date: February 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 90 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center - Center for Neuromodulation	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Vibhor Krishna

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify and record LFP	The association between local field potential (LFP) signals in individuals who have undergone deep brain stimulation (DBS) of the subthalamic nucleus (STN) and successful completion of a cursor drive motor task.	18 months	No