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

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activa PC+S
Sponsored by
Vibhor Krishna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease

Eligibility Criteria

22 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University Wexner Medical Center - Center for Neuromodulation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS LFP Activa PC+S

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2015
Last Updated
November 16, 2016
Sponsor
Vibhor Krishna
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1. Study Identification

Unique Protocol Identification Number
NCT02731365
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study stopped to await new generation of device anticipated to be released 2018.
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vibhor Krishna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBS LFP Activa PC+S
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Activa PC+S
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identify and record LFP
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Rezai, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center - Center for Neuromodulation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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