Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Closed Loop DBS Implanted RC+S Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03815656
Recruitment Status : Active, not recruiting
First Posted : January 24, 2019
Last Update Posted : March 23, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Duke University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Dennis Turner, M.D., Duke University

Brief Summary:

This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:

  1. to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and
  2. to develop an adaptive DBS system using brain signals measured from these two electrodes.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: STN alone Device: GPi alone Device: STN + GPi Device: Closed-loop stimulation Not Applicable

Detailed Description:

The purpose of this study is a small, first in man, clinical feasibility trial for patients with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain stimulation (DBS) with two goals:

  1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of the brain; and
  2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from these two electrodes.

The study will involve bilateral dual DBS electrode placement in clinically standard locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. In addition, patients will undergo intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and DBS lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research IPG.

The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system that simultaneously measures the DBS local evoked potential (DLEP) and/or local field potential (LFP) responses from either the same or a second DBS electrode.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC+S Studies)
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Implanted RC+S
Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
Device: STN alone
DBS stimulation of STN alone

Device: GPi alone
DBS stimulation of GPi alone

Device: STN + GPi
cooperative DBS stimulation of STN and GPi sites

Device: Closed-loop stimulation
adaptive DBS stimulation of STN and/or GPi sites




Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation [ Time Frame: 12 months after IPG implant ]
    UPDRS score for subject in "on" medication and "on" stimulation state. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).

  2. Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation [ Time Frame: 24 months after IPG implant ]
    UPDRS score for subject in "on" medication and "on" stimulation state. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).


Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation [ Time Frame: 12 months and 24 months after IPG implant ]
    UPDRS-III (Motor Evaluation) score in "off" medication and "on" stimulation state. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).

  2. percentage of waking hours with good "on" time [ Time Frame: baseline, 12 months and 24 months after IPG implant ]
    percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary

  3. Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score [ Time Frame: 12 months and 24 months after IPG implant ]
    The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able to give informed consent
  • diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
  • has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
  • has off-on improvement with levodopa of at least 30%
  • is available for follow-up visits for length of study

Exclusion Criteria:

  • is not safe surgical candidate for DBS
  • has severe neurological injury or disease other than Parkinson's Disease
  • has condition requiring repeated MRI scans
  • has untreated, clinically significant depression
  • has an electrical or electromagnetic implant
  • had a prior thalamotomy or surgical ablation procedure
  • has dementia interfering with ability to comply with study requirements or give informed consent
  • abuses drugs or alcohol
  • has a history of seizures
  • has any metallic implants
  • is pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815656


Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Dennis Turner, M.D.
National Institutes of Health (NIH)
Duke University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Dennis A Turner, M.D. Duke University
Layout table for additonal information
Responsible Party: Dennis Turner, M.D., Professor of Neurosurgery, Duke University
ClinicalTrials.gov Identifier: NCT03815656    
Other Study ID Numbers: Pro00100982
UH3NS103468 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Dennis Turner, M.D., Duke University:
Deep Brain Stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases