Clinical trial NCT00360009: Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease
Official title: Cognition and Mood in Parkinson's Disease (PD) in Subthalamic Nucleus (STN) Versus Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: 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
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-08-03
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Afraid State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Confused State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Energetic State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Happy State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Sad State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Tense State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Visual Analogue Mood Scales (VAMS) Tired State
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
Secondary outcomes:
measure: Change in Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Beck Depression Inventory (BDI)
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
measure: Change in Letter Fluency Tasks (LFT)
timeFrame: Pre-surgery baseline to 6 months of DBS stimulation
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100
state: Florida
Study officials:
affiliation: University of Florida
name: Michael Okun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Kelly Foote, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Hubert Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Ramon Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: