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The goal of this trial is to evaluate the preliminary safety and efficacy of programming to maximize stimulation of the dorsolateral region of the subthalamic nucleus (STN) receiving primary motor (M1) and supplementary motor area (SMA), but not pre-SMA, input deep brain stimulation (DBS) in patients with early-stage Parkinson's disease (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active subthalamic nucleus deep brain stimulation plus optimal drug therapy | Experimental | active subthalamic nucleus deep brain stimulation; plus optimal drug therapy |
|
| inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy | Active Comparator | inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active subthalamic nucleus deep brain stimulation plus optimal drug therapy | Device | active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| frequency and severity of adverse events | frequency and severity of adverse events | 24 months |
| frequency and severity of adverse cognitive outcome | decline from baseline at ≥ 1.5 SD (modest) and ≥ 2.0 (substantial) in tests comprising a comprehensive neuropsychological battery | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stopped or Reversed Motor Progression | compare changes in motor progression for active DBS+ODT vs inactive DBS+ODT | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
Dementia as evidenced by a Dementia Rating Score of less than 123.
Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
Currently active diagnosis of a major psychiatric disorder.
Previous brain operation or injury.
Active participation in another clinical trial for the treatment of PD.
Subjects with cardiac pacemakers or medical conditions that require repeat MRI scans.
Evidence of existing dyskinesia
Any current substance use disorder.
Any history of recurrent or unprovoked seizures.
Any prior movement disorder treatments that involved intracranial surgery or device implantation.
Any other active implanted intracranial device (e.g., cochlear implant) or implanted device to treat movement disorders (e.g., duodopa pump) whether turned on or off.
A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
History of suicide attempt.
A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Inability or unwillingness of subject to give written informed consent.
Parkinsonian features restricted to the lower limbs for more than three years.
Treatment with a dopamine receptor blocker or a dopamine-depleting agent in a dose and time course consistent with drug-induced parkinsonism.
Normal functional neuroimaging of the presynaptic dopaminergic system, as measured by DaTSCAN.
Rapid progression of gait impairment requiring regular use of a wheelchair.
Early bulbar dysfunction, defined as one of severe dysphonia, dysarthria (speech unintelligible most of the time), or dysphagia (requiring soft food, nasogastric (NG) tube, or gastrostomy feeding).
Inspiratory respiratory dysfunction defined as either diurnal or nocturnal inspiratory stridor or frequent inspiratory sighs.
Recurrent (>1/year) falls because of impaired balance within 3 years of onset.
Otherwise unexplained pyramidal tract signs, defined as pyramidal weakness or clear pathologic hyperreflexia (excluding mild reflex asymmetry in the more affected limb and isolated extensor plantar response).
Bilateral symmetric parkinsonism throughout the disease course. The patient or caregiver reports bilateral symptom onset with no side predominance, and no side predominance is observed on objective examination.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mallory Hacker, PhD, MSCI | Contact | 1-615-875-7437 | mallory.hacker@vumc.org |
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motor scores will be blindly rated by an independent movement disorders neurologist who will be unaware of treatment assignment, ON vs OFF treatment status, or visit sequence
| inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy | Device | optimal drug therapy alone with DBS device turned off |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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