Suspended

DBSNeurocognitive Effects of Bilateral Subthalamic Nucleus Versus Globus Pallidus Interna Deep Brain Stimulation in Parkinson's Disease Patients With Mild Cognitive Impairment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Bilateral GPi DBS

+ Bilateral STN DBS

Device
Who is being recruted

Synucleinopathies+11

+ Basal Ganglia Diseases

+ Mental Disorders

Over 21 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorSt. Joseph's Hospital and Medical Center, Phoenix
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleNeurocognitive Effects of Bilateral Subthalamic Nucleus Versus Globus Pallidus Interna Deep Brain Stimulation in Parkinson's Disease Patients With Mild Cognitive Impairment
Principal SponsorSt. Joseph's Hospital and Medical Center, Phoenix
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesNeurocognitive DisordersParkinsonian DisordersCognitive Dysfunction

Criteria

4 inclusion criteria required to participate
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

2 exclusion criteria prevent from participating
no diagnosis of Parkinson's disease

not appropriate for DBS surgery

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Procedure: deep brain stimulation surgery

Group II

Active Comparator
Procedure: deep brain stimulation surgery

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Barrow Neurological Institute / St. Joseph's Hospital & Medical Center

Phoenix, United StatesOpen Barrow Neurological Institute / St. Joseph's Hospital & Medical Center in Google Maps
SuspendedOne Study Center