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

November 16, 2016 updated by: Vibhor Krishna

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center - Center for Neuromodulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DBS LFP Activa PC+S
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify and record LFP
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vibhor Krishna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

April 2, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014H0423

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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