Effects of Deep Brain Stimulation for the Treatment of Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00358189
First received: July 28, 2006
Last updated: February 3, 2009
Last verified: July 2006
  Purpose

The purpose of this study is to assess the effects of unilateral deep brain stimulation on upper and lower extremity motor function in advanced Parkinson's disease patients. It is hypothesized the unilateral stimulation will lead to improvements in bilateral motor functioning.


Condition Intervention
Parkinson
Device: Deep Brain Stimulation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Deep Brain Stimulation and Motor Function in Parkinson's Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 20
Study Start Date: October 2006
Study Completion Date: May 2008
Detailed Description:

Parkinson's disease (PD) is a chronic progressive degenerative illness in which dopaminergic neurons in the substantia nigra pars compacta deteriorate resulting in a reduction in striatal dopamine. Decreased levels of dopamine in PD patients results in varying combinations of akinesia, bradykinesia, tremor, rigidity and gait\postural instability. Parkinson's disease is the second most common neurodegenerative disorder, affecting nearly 1.2 million Americans with annual treatment costs approaching $25 billion. Deep brain stimulation (DBS) is a surgical approach developed for the treatment of advanced PD that provides promise in alleviating its motor deficits. The most common stimulation site for the treatment of advanced PD is the subthalamic nucleus (STN). Nearly 90 percent of patients involved in a multi-center trial with STN stimulation underwent single session bilateral implantation. It is generally accepted that bilateral STN stimulation improves upper and lower extremity function. However, bilateral STN stimulation may be associated with postoperative morbidity including cognitive deficits and neuropsychiatric changes. In contrast, the effects of unilateral STN stimulation on bilateral upper and lower extremity motor function are poorly understood. The question of whether to proceed with bilateral or unilateral surgery is important, as a significant number of patients for whom surgery is a consideration have relative contraindications such as age greater than 70, cognitive decline, or other medical conditions that may prevent bilateral implantation. Considering the risks for bilateral implantation may be greater than unilateral procedures, it is necessary to determine if unilateral stimulation is an effective means of ameliorating PD symptoms. The primary aim of this collaborative project is to determine the effects of unilateral STN DBS on functional upper (manual dexterity) and lower (postural stability and gait initiation) extremity motor performance in Veterans with advanced PD. The results from these studies have the potential to impact the use of DBS in the treatment of advanced PD. Positive bilateral results with unilateral stimulation of STN may allow patients not currently considered eligible for bilateral implantation to be considered for unilateral procedures as a method of treating PD symptoms. Our general hypothesis is that unilateral STN DBS acts to override disrupted neural activity of the basal ganglia in one hemisphere. The resultant normalized basal ganglia output to the SMA then allows for improved planning and control of bilateral actions. Bilateral upper and lower extremity motor performance will be quantified in a group of advanced PD patients with unilateral STN DBS patients while "on" and "off" stimulation. It is hypothesized that unilateral STN DBS will result in bilateral improvements in upper and lower extremity motor function.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a) Patients must have had the Deep Brain Stimulator implanted for at least six months prior to enrollment.
  • Hoehn and Yahr stage III or worse when off stimulation and medication
  • Intractable, disabling motor fluctuations, dyskinesias or freezing episodes
  • Age between 30-75 years
  • Normal cognition
  • Demonstrated good response to levodopa. In order to exclude patients with Parkinson's plus (i.e. progressive supranuclear palsy, multiple system atrophy, striato-nigral degeneration, etc) all patients included in this study must have demonstrated a good response to levodopa, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based on UPDRS motor examination subscore following the administration of levodopa during their screening neurological exam.
  • Unsatisfactory clinical response to maximal medical management A stable and optimal medical regimen of antiparkinsonian drug therapy for at least three months prior to or after surgery

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:
  • History of CVA's, exposure to toxins, neuroleptics or encephalitis
  • Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy or significant orthostatic hypertension
  • Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain
  • Use of DBS for psychiatric disorder (obsessive compulsive or depression)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358189

Locations
United States, Ohio
Louis Stoke Cleveland VA Medical Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Investigators
Principal Investigator: Jay L Alberts, PhD Investigator
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00358189     History of Changes
Other Study ID Numbers: B4061I
Study First Received: July 28, 2006
Last Updated: February 3, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
deep brain stimulation
gait
manual dexterity
parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 18, 2014