Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) SurgeryNCT03608228
Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks
An observational study of Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery
- What is being tested?
- Measuring electrical signals from the brain
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2016to 10 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18
- Rigid-akinetic subtype of Parkinson's disease, diagnosed by a movement disorders neurologist
- 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
- Preoperative MRI without cortical or subdural adhesions or vascular abnormalities
- Subject is medically fit for surgical intervention, as deemed by a primary care physician
Who cannot join
- Inability or unwillingness to tolerate 20 minutes and up to 40 minutes of additional operative time
- Patient with history of secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's disease.
- 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.
- 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).
- Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
- Subject has history of bleeding or immune compromise.
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- Subject has history of implant-related infection.
- Subject has a prior history of seizures or epilepsy.
- 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.
- Subject has a significant abnormality on preoperative brain MRI
- Subject has had prior craniotomy or brain surgery.
- Subject has significant memory impairment (based on Montreal Cognitive Assessment (MoCA) < 23).
- Subject has a disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
- Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
- Does not speak a principal language associated with the region
- Hearing loss that prevents adequate communication with researchers.
- Subject has moderate or severe depression (HAMD ≥ 17)
- Subject is implanted with any neuromodulation device in the head including, but not limited to cochlear implant, deep brain stimulator, or auditory brain implant.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Measuring electrical signals from the brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring electrical signals from the brainOther
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 group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Not described Receives: Other: Measuring electrical signals from the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start6 Dec 2016
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608228
- Sponsor's protocol ID
- 16-001516
- Status last verified
- Sep 2021
- First submitted
- 24 Jul 2018
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Approach to Model Human Cortex-Basal Ganglia Action-Regulating Networks
- ClinicalTrials.gov ID
- NCT03608228
- Acronym / sponsor ID
- 16-001516
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, University of California, San Francisco, University of California, San Diego, California Institute of Technology, Cedars-Sinai Medical Center
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Other: Measuring electrical signals from the brain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age > 18
- Rigid-akinetic subtype of Parkinson's disease, diagnosed by a movement disorders neurologist
- 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
- Preoperative MRI without cortical or subdural adhesions or vascular abnormalities
- Subject is medically fit for surgical intervention, as deemed by a primary care physician
Key exclusion criteria (18 listed)
- Inability or unwillingness to tolerate 20 minutes and up to 40 minutes of additional operative time
- Patient with history of secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's disease.
- 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.
- 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).
- Patients with recent use (within one week) of anticoagulant or antiplatelet agent use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring electrical signals from the brainIf 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. | Other | Parkinson's Disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease Patients Undergoing Deep Brain Stimulation (DBS) Surgery, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in neural signals related to stopping and conflicting movements (time frame: Up to 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021; AzTrials last refreshed its copy on 28 Oct 2026.