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Neural Signatures of Parkinson's Disease (BrainRadio)

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ClinicalTrials.gov Identifier: NCT01990313
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : January 16, 2018
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Helen M. Bronte-Stewart, Stanford University

Tracking Information
First Submitted Date  ICMJE November 6, 2013
First Posted Date  ICMJE November 21, 2013
Results First Submitted Date  ICMJE December 15, 2017
Results First Posted Date  ICMJE January 16, 2018
Last Update Posted Date February 20, 2018
Study Start Date  ICMJE October 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Change in Resting State Beta Band Power Over Time [ Time Frame: Baseline and 1 Year ]
    We compared the beta band (13-30 Hz) power in the neural signal at the initial programming visit (baseline) and at the 12 month follow-up visit (1 year) after turning off deep brain stimulation therapy. Beta band power is normalized to average beta band power at the initial programming visit. Using a linear mixed model for repeated measures over time, regression beta coefficient was obtained to determine if beta power changed significantly between the initial programming and the 12 month follow-up visit.
  • Sample Beta Entropy [ Time Frame: 1 day ]
    Sample entropy is a measure of estimated conditional predictability, calculated within a frequency range of a patient's local field potential. Freezers are subjects who have clinical history of freezing of gait symptoms and/or if the subject displayed freezing behavior pre-operatively or during the in-study gait tasks relative to non-freezers, those who have never experienced freezing of gait. We measured sample beta (13-30 Hz) entropy in subjects' local field potential. Higher values of sample entropy indicate lower estimated conditional predictability. Testing occurred over one day, at a range of approximately 1 month to 7 months post DBS device implantation.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2013)
The changes of neuronal oscillations, measured in power (dB/Hz) and frequency (Hz) that are significantly different during tremor, repetitive movement and freezing episodes from those at rest in people with Parkinson's disease off medications. [ Time Frame: 2 Years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neural Signatures of Parkinson's Disease
Official Title  ICMJE Neural Signatures of Tremor, Bradykinesia and Freezing in the Subthalamic Region on Parkinson's Disease and Their Acute and Long-Term Modulation by Subthalamic Deep Brain Stimulation.
Brief Summary The purpose of this study is to provide objective measurements of abnormal movements of the body in correlation with neural activity of the brain and track how these change over time. This may allow for the development of objective evaluation of the neural activity causing abnormal movements, which may lead to the ability of the DBS system to stimulate the brain by sensing the abnormal neural activity that is causing abnormal movements.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Device: Activa PC+S
The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
Other Name: Model 37604
Study Arms  ICMJE Experimental: Activa PC+S
Intervention: Device: Activa PC+S
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2013)
10
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • a diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II.
  • Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication.
  • The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.
  • Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized (during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study.
  • Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist.
  • Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.
  • Age > 18

Exclusion Criteria:

  • Subjects with significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery.
  • Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and as scored on a validated depression assessment scale.
  • Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory).
  • Age > 80.
  • Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump.
  • Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding.
  • Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI
  • Subjects having a major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin).
  • Subjects having any prior intracranial surgery.
  • Subjects with a history of seizures.
  • Subjects, who are immunocompromised.
  • Subjects with an active infection.
  • Subjects, who require diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition.
  • Subjects, who have an inability to comply with study follow-up visits.
  • Subjects, who are unable to understand or sign the informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01990313
Other Study ID Numbers  ICMJE 25916
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helen M. Bronte-Stewart, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: Helen Bronte-Stewart, MD,MSE,FAAN Stanford University
PRS Account Stanford University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP