Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01870518
Recruitment Status : Terminated (Lack of enrollment)
First Posted : June 6, 2013
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Mild Cognitive Impairment Dementia Device: Bilateral GPi DBS Device: Bilateral STN DBS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurocognitive Effects of Bilateral Subthalamic Nucleus Versus Globus Pallidus Interna Deep Brain Stimulation in Parkinson's Disease Patients With Mild Cognitive Impairment
Study Start Date : April 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870518


Locations
Layout table for location information
United States, Arizona
Barrow Neurological Institute / St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Layout table for investigator information
Principal Investigator: Francisco A Ponce, MD Barrow Neurological Institute / St. Joseph's Hospital & Medical Center
Publications:

Layout table for additonal information
Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01870518    
Other Study ID Numbers: 13BN006
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Parkinson's disease
Dementia
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Dementia
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders