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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03608228
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : September 24, 2019
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

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.

Condition or disease Intervention/treatment
Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery Other: Measuring electrical signals from the brain

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks
Actual Study Start Date : December 6, 2016
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Parkinson's Disease 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.

Primary Outcome Measures :
  1. 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.

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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 identifier (NCT number): NCT03608228

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Contact: Nader Pouratian, MD PhD (310)206-2189
Contact: Diana Babayan, MPH (310)267-9454

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United States, California
Nader Pouratian Recruiting
Los Angeles, California, United States, 90095
Contact: Nader Pouratian, MD PhD         
Sponsors and Collaborators
University of California, Los Angeles
The Cleveland Clinic
University of California, San Francisco
University of California, San Diego
California Institute of Technology
Cedars-Sinai Medical Center

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Responsible Party: Nader Pouratian, Principal Investigator, University of California, Los Angeles Identifier: NCT03608228    
Other Study ID Numbers: 16-001516
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases