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Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks

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ClinicalTrials.gov Identifier: NCT03608228
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
The Cleveland Clinic
University of California, San Francisco
University of California, San Diego
California Institute of Technology
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Nader Pouratian, University of California, Los Angeles

Tracking Information
First Submitted Date July 24, 2018
First Posted Date July 31, 2018
Last Update Posted Date September 24, 2019
Actual Study Start Date December 6, 2016
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2018)
Differences in neural signals related to stopping and conflicting movements [ Time Frame: Up to 40 minutes ]
Patients will be asked to perform hand movements in response to either a go signals, a conflict signal, or a stopping signal.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03608228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks
Official Title Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks
Brief Summary The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological diseases, like Parkinson's disease, cause abnormalities in the brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases. Through this research, the investigators will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks. This study aims to enroll up to 75 subjects over a period of 2.5 years. Those who participate in the study will spend up to 40 minutes during their deep brain stimulation surgery during which researchers will record signals from deep structures within the brain as well as the surface of the brain using electrodes that are temporarily placed for research purposes. During the study, researchers will record signals while subjects perform three different tasks, in some cases while the brain is stimulated. Study participation is limited to the intraoperative environment with no additional study visits required.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects are patients who are undergoing deep brain stimulation implantation for treatment of Parkinson's disease based on clinical indications as determined by a multidisciplinary neurology-neurosurgery team at each center.
Condition Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery
Intervention Other: Measuring electrical signals from the brain
If patients participate in this study, after the deep brain stimulator leads have been implanted, the researcher(s) will plan to measure electrical signals from the brain while patients perform hand movement tasks.
Study Groups/Cohorts Parkinson's Disease
Intervention: Other: Measuring electrical signals from the brain
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 24, 2018)
36
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age > 18
  2. Rigid-akinetic subtype of Parkinson's disease, diagnosed by a movement disorders neurologist
  3. Clinical indications, as deemed by a multidisciplinary team of neurologists and neurosurgeons, for deep brain stimulation surgery, including motor fluctuations, difficult-to-control-dyskinesias, unpredictable off-times, and/or dystonia
  4. Preoperative MRI without cortical or subdural adhesions or vascular abnormalities
  5. Subject is medically fit for surgical intervention, as deemed by a primary care physician

Exclusion Criteria:

  1. Inability or unwillingness to tolerate 20 minutes and up to 40 minutes of additional operative time
  2. Patient with history of secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's disease.
  3. Subject is at high risk for surgical complications such as active systemic infection, coagulation disorders (such as the use of anti-thrombotic therapies) or platelet count below 100,000.
  4. Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile (either (Partial Thromboplastin Time) PTT or prothrombin time/INR).
  5. Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
  6. Subject has history of bleeding or immune compromise.
  7. Subject has history of implant-related infection.
  8. Subject has a prior history of seizures or epilepsy.
  9. Subject has a clinically significant or unstable medical condition including uncontrolled systemic hypertension with values above 170/100; cardiac or pulmonary disease; uncorrected coagulation abnormalities; diabetes; or any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
  10. Subject has a significant abnormality on preoperative brain MRI
  11. Subject has had prior craniotomy or brain surgery.
  12. Subject has significant memory impairment (based on Montreal Cognitive Assessment (MoCA) < 23).
  13. Subject has a disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:

    1. Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
    2. Does not speak a principal language associated with the region
    3. Hearing loss that prevents adequate communication with researchers.
  14. Subject has moderate or severe depression (HAMD ≥ 17)
  15. Subject is implanted with any neuromodulation device in the head including, but not limited to cochlear implant, deep brain stimulator, or auditory brain implant.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nader Pouratian, MD PhD (310)206-2189
Contact: Diana Babayan, MPH (310)267-9454
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03608228
Other Study ID Numbers 16-001516
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nader Pouratian, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators
  • The Cleveland Clinic
  • University of California, San Francisco
  • University of California, San Diego
  • California Institute of Technology
  • Cedars-Sinai Medical Center
Investigators Not Provided
PRS Account University of California, Los Angeles
Verification Date September 2019