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Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease

NCT ID: NCT00360009

Last Updated: 2012-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.

Detailed Description

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Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and the globus pallidus interna (GPi) has been shown to relieve the motor symptoms of Parkinson's disease (PD) such as tremor, rigidity, and bradykinesia. However, there is increasing evidence that DBS may be associated with a significant number of mood and cognitive changes.

The aims of this study are to characterize and compare the mood and cognitive effects associated with DBS of the STN and GPi, to delineate regions within or around the STN and GPi that are associated with specific mood and cognitive changes when DBS is applied to these areas, and to assess the relative effectiveness of right versus left STN or GPi stimulation on mood and cognition.

In the study, researchers will compare motor, mood, and cognitive function in people with PD who have had DBS treatment with control subjects (or individuals with PD who have not had DBS). The scientists will characterize the types and incidence of mood and cognitive changes that occur during DBS in each target (STN and GPi), compare the targets, and examine the role of lead location.

The study will enroll 62 participants-10 control subjects (individuals with PD who have not had DBS), and 52 individuals with PD who are scheduled for DBS; the site of the implant (STN or GPi) will be randomly assigned. Participants will perform motor, mood, and cognitive tests (following 6 months of stimulation) over a 2-day period. Duration of the trial for participants is 6 months and includes a 2-night hospital stay.

Findings from this study may help researchers better understand how DBS affects non-motor circuitry.

Conditions

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Parkinson Disease

Keywords

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Parkinson's disease Parkinson disease PD deep brain stimulation DBS subthalamic nucleus STN globus pallidus interna GPi mood motor symptoms cognition emotion memory attention tremor rigidity bradykinesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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STN DBS

Patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's disease (PD)

Group Type ACTIVE_COMPARATOR

DBS of the STN

Intervention Type PROCEDURE

Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.

GPI DBS

Patients who underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) to treat Parkinson's disease (PD)

Group Type ACTIVE_COMPARATOR

DBS of the GPI

Intervention Type PROCEDURE

Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.

no DBS

non-DBS PD patient control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DBS of the STN

Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.

Intervention Type PROCEDURE

DBS of the GPI

Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Intractable, disabling PD with motor fluctuations, dyskinesias, or freezing episodes
* Age between 30-75 years
* Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-Parkinsonian drugs)
* A stable and optimal medical regimen of anti-Parkinsonian drug therapy for at least three months prior to surgery
* Patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.

Exclusion Criteria

* Clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)
* Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension
* MRI scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)
* The Mattis Dementia Rating Scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia
* A major psychiatric disorder on the Structured Clinical Interview for DSM-IV (SCID-IV).
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Okun, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Kelly Foote, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Hubert Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Ramon Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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K23NS044997

Identifier Type: NIH

Identifier Source: secondary_id

View Link

303-2002

Identifier Type: -

Identifier Source: org_study_id