AzTrials
AzTrials

ParkinsonNCT00358189

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

An observational study of Parkinson, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Parkinson
What is being tested?
Deep Brain Stimulation
Type of treatment
Medical device
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2006to May 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Louis Stoke Cleveland VA Medical Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Deep Brain Stimulation and Motor Function in Parkinson's Patients

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.

Read the 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.

Conditions
Parkinson
Being tested
Deep Brain Stimulation
Keywords
deep brain stimulation, gait, manual dexterity, parkinson's disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain StimulationDevice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2006 (estimated)
  2. Study startOct 2006
  3. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00358189
Sponsor's protocol ID
B4061I
Status last verified
Jul 2006
First submitted
28 Jul 2006
Last updated
5 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in