Neurocognitive Effects of Bilateral STN Versus GPi DBS in Parkinson's Disease Patients With MCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-02-29

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Parkinson's Disease Mild Cognitive Impairment Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Parkinson's patients with MCI

Procedure: deep brain stimulation surgery

Group Type ACTIVE_COMPARATOR

Bilateral GPi DBS

Intervention Type DEVICE

Bilateral STN DBS

Intervention Type DEVICE

Parkinson's patients without MCI

Procedure: deep brain stimulation surgery

Group Type ACTIVE_COMPARATOR

Bilateral GPi DBS

Intervention Type DEVICE

Bilateral STN DBS

Intervention Type DEVICE

Interventions

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Bilateral GPi DBS

Intervention Type DEVICE

Bilateral STN DBS

Intervention Type DEVICE

Eligibility Criteria

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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