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CompletedNCT03608228Updated Oct 7, 2021

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

An observational study in Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-07.

Sponsored by University of California, Los Angeles · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
27
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 27 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • Parkinson's Disease

    Other: Measuring electrical signals from the brain

Interventions

  • OtherMeasuring 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.

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What researchers measure

Primary outcomes

  1. Differences in neural signals related to stopping and conflicting movements

    Patients will be asked to perform hand movements in response to either a go signals, a conflict signal, or a stopping signal.

    Time frame: Up to 40 minutes

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Study locations

1 site
  • Nader Pouratian
    Los Angeles, California 90095, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03608228
Lead 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
Responsible party
Sponsor
First posted
Jul 31, 2018
Start date
Dec 6, 2016
Primary completion
Nov 10, 2020
Completion
Nov 10, 2020
Last update
Oct 7, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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