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

NCT00360009 | Completed Results DMC

• 2 other identifiers: 303-2002K23NS044997
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (8)

• Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Afraid State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Confused State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Energetic State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Happy State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Sad State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Tense State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Visual Analogue Mood Scales (VAMS) Tired State

  VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.

  Pre-surgery baseline to 6 months of DBS stimulation

Secondary Outcomes (3)

• Change in Spielberger State-Trait Anxiety Inventory (STAI)

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Beck Depression Inventory (BDI)

  Pre-surgery baseline to 6 months of DBS stimulation

• Change in Letter Fluency Tasks (LFT)

  Pre-surgery baseline to 6 months of DBS stimulation

Study Arms (3)

STN DBS

ACTIVE COMPARATOR

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

Procedure: DBS of the STN

GPI DBS

ACTIVE COMPARATOR

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

Procedure: DBS of the GPI

no DBS

NO INTERVENTION

non-DBS PD patient control group

Interventions

DBS of the STN PROCEDURE

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

STN DBS

DBS of the GPI PROCEDURE

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

GPI DBS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

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

Gainesville, Florida, 32610-0236, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor; Muscle Rigidity; Hypokinesia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Results Point of Contact

• Title: Michael Okun, M.D.
• Organization: University of Florida Department of Neurology

okun@neurology.ufl.edu

352-273-5550

Study Officials

• Michael Okun, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Kelly Foote, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Hubert Fernandez, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Ramon Rodriguez, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 3, 2006
• Study Start: January 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 31, 2012
• Results First Posted: February 2, 2010

Record last verified: 2012-10

Locations

US (1)