Neurocognitive Effects of Bilateral STN Versus GPi DBS in Parkinson's Disease Patients With MCI
| Status: | Terminated |
|---|---|
| Conditions: | Cognitive Studies, Parkinsons Disease, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/14/2017 |
| Start Date: | April 2013 |
| End Date: | February 2016 |
Neurocognitive Effects of Bilateral Subthalamic Nucleus Versus Globus Pallidus Interna Deep Brain Stimulation in Parkinson's Disease Patients With Mild Cognitive Impairment
Purpose: This is a prospective single-center, randomized, patient and evaluator-blind
clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus
subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients
with mild cognitive impairment (MCI).
clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus
subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients
with mild cognitive impairment (MCI).
Deep brain stimulation (DBS) of the globus pallidus interna (GPi) or subthalamic nucleus
(STN) has been accepted as the surgical treatment of choice for patients with advanced
Parkinson's Disease (PD), demonstrating improvements in motor function that exceed those
achieved by medical management alone. Unfortunately, a paucity of data exist comparing
non-motor outcomes between DBS of the available targets. Specifically, a high prevalence of
concurrent cognitive dysfunction or early dementia exists in PD patients, and it is unclear
whether DBS target selection may have differential effects with regards to cognitive outcomes
in PD patients with early evidence of mild cognitive impairment Previous studies indicate
that stimulation of either the GPi or STN is associated with decrements in patients' verbal
fluency, visuospatial memory, as well as overall cognitive decline, but those patients were
randomized without consideration for baseline neurocognitive performance and it is unclear
whether these effects are due to treatment or rather the natural history of these patients.
In addition to the clinical arm of this trial, another secondary goal is to evaluate several
biomarkers obtained from blood and cerebrospinal in order to determine their utility if any
as prognosticators of patient cognitive and motor outcomes. Specifically, we will be
evaluating levels of amyloid 1-42, total tau, phosphorylated tau 181, and brain derived
neurotrophic factor in the cerebrospinal fluid as well as genotyping the apolipoprotein-E
gene. These proteins and genotypes are still currently under investigation as potential
biomarkers for dementia as well as neuroplasticity.
(STN) has been accepted as the surgical treatment of choice for patients with advanced
Parkinson's Disease (PD), demonstrating improvements in motor function that exceed those
achieved by medical management alone. Unfortunately, a paucity of data exist comparing
non-motor outcomes between DBS of the available targets. Specifically, a high prevalence of
concurrent cognitive dysfunction or early dementia exists in PD patients, and it is unclear
whether DBS target selection may have differential effects with regards to cognitive outcomes
in PD patients with early evidence of mild cognitive impairment Previous studies indicate
that stimulation of either the GPi or STN is associated with decrements in patients' verbal
fluency, visuospatial memory, as well as overall cognitive decline, but those patients were
randomized without consideration for baseline neurocognitive performance and it is unclear
whether these effects are due to treatment or rather the natural history of these patients.
In addition to the clinical arm of this trial, another secondary goal is to evaluate several
biomarkers obtained from blood and cerebrospinal in order to determine their utility if any
as prognosticators of patient cognitive and motor outcomes. Specifically, we will be
evaluating levels of amyloid 1-42, total tau, phosphorylated tau 181, and brain derived
neurotrophic factor in the cerebrospinal fluid as well as genotyping the apolipoprotein-E
gene. These proteins and genotypes are still currently under investigation as potential
biomarkers for dementia as well as neuroplasticity.
Inclusion Criteria:
- clinical diagnosis of idiopathic Parkinson's disease
- deemed an appropriate candidate for DBS surgery
- Montreal Cognitive Assessment (MoCA) score < 25
- Neuropsychological testing with the diagnosis of Mild Cognitive Impairment
Exclusion Criteria:
- no diagnosis of Parkinson's disease
- not appropriate for DBS surgery
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