• PDTrials - Parkinson's Disease Clinical Trials
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Official Study Title: Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease
Sponsor: Vanderbilt University
Clinicaltrials.gov ID: NCT00282152
Study ID: 040797

Summary

Levodopa  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. is commonly used as a treatment for many people who are diagnosed with Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Often times these people encounter levodopa-induced motor complications as a result, which can include problems with walking, freezing of gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. and other issues.

B-STN DBS (deep brain stimulation)  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. is one of the most effective surgical treatments for people with PD who suffer from levodopa-induced motor complications. This procedure has a relatively low incidence of permanent adverse effects, as well as the potential for neuroprotection  NeuroprotectionRelating to mechanisms within the nervous system that can slow or stop the progression of PD by protecting neurons from cellular damage caused by the disease. and alteration of the natural course of PD. These results suggest a highly favorable benefit-to-risk ratio of this procedure.

Neuroprotection can be a medication or treatment that aims to slow or stop the progression of PD. Since neuroprotection is best applied early in the disease course when there are more surviving neurons in the brain, the researchers for this study believe that further investigation of this procedure is warranted.

This pilot study is designed to collect the preliminary safety and tolerability data necessary to conduct a future phase III clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. study. The phase III study will investigate the hypothesis that deep brain stimulation of the subthalamic nucleus in the brain of people with early Parkinson's will slow the progression of the disease. The study will compare the safety and tolerability of B-STN DBS plus optimal drug therapy  TherapyAnother word for “treatment”. vs. optimal drug therapy alone (control, standard of care) in 30 people (15 per group) with early PD.

Study Phase

Phase 1
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Walking/Gait, Tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. Swallowing difficulty, Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Postural difficulties, Muscle Pain, Masked Face,  Masked FaceLoss of facial expression and reduced blink rate and eye movement make a person appear to be staring off in the distance, which can be misinterpreted as lack of interest or depression. General PD symptoms, Balance

Time Commitment

• More than six months
• Five one-week long stays in the Vanderbilt Hospital, every six months, for a total of two years Follow-up consists of a phone call at 3 years and a clinic visit at 4 years

Eligibility

• Minimum Age: 50
• Maximum Age: 75
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosed with PD
• Demonstrated response to anti-Parkinson's drugs
• Able to undergo surgery
• Available for follow-up for four years
• Participant is willing and able to sign consent form
• MRI (magnetic resonance imaging  Magnetic Resonance Imaging (MRI)A non-invasive technique that uses magnetism to create detailed pictures of the inside of the human body. test) results within normal range for age
• Must have taken Levodopa or dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. agonist therapy for greater than six months but less than four years

Exclusion Criteria

• Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)
• Diagnosed with dementia  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality. (can be defined as a decline in intellectual understanding or capacity)
• Major psychiatric disorder
• Previous brain operation or injury
• Active participation in another clinical trial  Clinical Trial (Clinical Study)A scientific study involving human participants to determine the safety and efficacy of new therapies or new ways of using known treatments. for the treatment of PD.
• Participants who have a cardiac pacemaker or certain other implanted medical devices
• People who have medical conditions that require repeat MRI scans or diathermy treatments.
• Existing dyskinesias or motor fluctuations

Enrollment

Expected Enrollment: 30 (US)
Date Enrollment Began: Jul 01 2006
Last Updated Date: Oct 27 2006
Trial Post Date: Oct 27 2006
Website: http://www.clinicaltrials.gov/ct/show/NCT00282152?order=1

Primary Contacts and Locations

Tennessee

• Odessa Lankford — Clinical Trials Specialist Sr.
  Vanderbilt University
  odessa.lankford@vanderbilt.edu
  Phone: (615) 343-2961
  Department of Neurology
  A-0118 MCN
  Nashville, TN 37232
  USA