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State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Activa PC+S
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of idiopathic Parkinson's Disease (PD).
  2. Age 45-75 years
  3. UPDRS III motor score (off PD medications) ≥ 25
  4. Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
  5. Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months
  6. Cleared to be scanned in a 7 tesla magnet
  7. Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process

Exclusion Criteria:

  1. Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease)
  2. Evidence of secondary or atypical parkinsonism
  3. Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
  4. Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker)
  5. Previous pallidotomy or DBS surgery
  6. Women who are currently pregnant or are breast feeding
  7. MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder
  8. Any prior intracranial surgery
  9. Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale
  10. History of seizures
  11. Immunocompromised
  12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
  13. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chronic brain recording

Arm Description

This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Outcomes

Primary Outcome Measures

Cortical and sub-cortical brain signals using Activa PC+S
Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2016
Last Updated
January 12, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02709148
Brief Title
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)
Official Title
State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in Parkinson's disease and how they relate to DBS and pharmacological management, not to bring new devices to market.
Detailed Description
Experimental: chronic brain recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

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
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chronic brain recording
Arm Type
Experimental
Arm Description
This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.
Intervention Type
Device
Intervention Name(s)
Activa PC+S
Intervention Description
DBS
Primary Outcome Measure Information:
Title
Cortical and sub-cortical brain signals using Activa PC+S
Description
Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of idiopathic Parkinson's Disease (PD). Age 45-75 years UPDRS III motor score (off PD medications) ≥ 25 Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds) Approved for unilateral subthalamic nucleus (STN)- or globus pallidus internus (GPi)-DBS surgery to treat their clinical motor signs and plan to undergo the standard of care procedure within the next four months Cleared to be scanned in a 7 tesla magnet Written documentation of willingness to participate in the study per protocol as evidenced by the informed consent process Exclusion Criteria: Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., significant cardiac or pulmonary disease) Evidence of secondary or atypical parkinsonism Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain. Unable to undergo magnetic resonance imaging (e.g., due to incompatible implanted pacemaker) Previous pallidotomy or DBS surgery Women who are currently pregnant or are breast feeding MRI showing cortical atrophy out of proportion to age and/or MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder Any prior intracranial surgery Subjects with depression defined according to Diagnostic and Statistical Manual V criteria and a scored on a validated depression assessment scale History of seizures Immunocompromised Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Vitek, MD, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With Deep Brain Stimulation (DBS)

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