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

February 9, 2016 updated by: St. Joseph's Hospital and Medical Center, Phoenix

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute / St. Joseph's Hospital & Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Parkinson's patients with MCI
Procedure: deep brain stimulation surgery
Device: Bilateral GPi DBS
Device: Bilateral STN DBS
ACTIVE_COMPARATOR: Parkinson's patients without MCI
Procedure: deep brain stimulation surgery
Device: Bilateral GPi DBS
Device: Bilateral STN DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive Function
Time Frame: 6 months post-operative
By focusing on patients with MCI, our primary aim will be to detect whether STN or GPi DBS incur target specific impacts on patients' subsequent neurocognitive function.Patients will undergo neuropsychological testing pre-operatively and again at six months post-operatively. Patient's will also undergo a Montreal Cognitive Assessment at specified intervals: pre-operatively, 3weeks, 6 weeks and 6 months post-operatively.
6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional motor improvements
Time Frame: 6 month post-operative
The secondary aim will be measure functional motor outcomes in our patients.Patient's will undergo Unified Parkinson's Disease Rating Scale (UPDRS 3 and 4) motor testing pre-operatively in the off medication and on medication states. Patients will be re-tested 6 months post-operatively in the following states: on device / off medication, off device / off medication, on device / on medication.
6 month post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Investigators

  • Principal Investigator: Francisco A Ponce, MD, Barrow Neurological Institute / St. Joseph's Hospital & Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (ESTIMATE)

June 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13BN006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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