Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks
Sponsor:
Brief Summary:
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.
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.
Locations
- Nader Pouratian, Los Angeles, California, United States, 90095
