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INTREPID Trial

Clinical Trial Title: 
Implantable neurostimulator for the treatment of Parkinson’s disease (INTREPID trial).
Clinical Trial Protocol ID: 
12100205
Clinical Trial Investigator Name: 
Leonardo Verhagen Metman, MD, PhD, and Sepehr B. Sani, MD
Clinical Trial Protocol Description: 

The purpose of this study is to determine if the study device is safe and effective for the treatment of patients with advanced Parkinson’s disease (PD) that is not adequately controlled by medication. The study will also evaluate changes in quality of life, dyskinesia (uncontrollable movements) severity, PD medications, and severity of other PD symptoms.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are 22-75 years of age.
  • Are diagnosed with PD with at least 2 symptoms for at least 5 years. Symptoms may include the following:
    • Resting tremor: an involuntary tremor occurring when the person is at rest.
    • Rigidity: stiffness.
    • Bradykinesia: extremely slow movement.
  • Have had no changes to your anti-parkinsonian medications for at least 28 days before beginning the trial.
  • Be an appropriate candidate for DBS.

You will be excluded from the study if any of the following criteria apply to you:

  • Have any significant psychiatric problems including untreated depression, any history of suicide attempt, or any skull abnormality that would make DBS surgery unsafe.
  • Have had any previous DBS surgery.
  • Be a woman who is breast-feeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

This is a partial list of inclusion and exclusion criteria. Additional evaluation for study eligibility will be done by your study doctor.

Clinical Trial Area: 
Parkinson's Disease and Other Movement Disorders
Contact Phone: 
(312) 563-1025
Contact Name: 
Francisco Acosta