Last updated on April 2018

Combined Subthalamic and Nucleus Basalis Meynert Deep Brain Stimulation for Parkinson's Disease With Dementia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dementia | Parkinson's Disease | Alzheimer's Disease
  • Age: Between 35 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age at the time of enrollment: 35 - 75 years.
  2. Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007)
  3. Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24
  4. Duration of bilateral idiopathic PD: 5 years of motor symptoms.
  5. Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage 2.
  6. UPDRS subset III score of 30 in the meds off, stim off state.
  7. Levodopa must improve PD symptoms by 30% in a levodopa challenge test, as measured by UPDRS subset III score.
  8. PDD with a symptom onset at least 2 years after first symptoms of PD
  9. Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary) if mentally competent or, if incompetent, their legally authorized representatives.
  10. Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed. If mentally incompetent, the legally authorized representative provides written informed consent

Exclusion Criteria:

  1. Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
  2. Any current drug or alcohol abuse.
  3. Any history of recurrent or unprovoked seizures.
  4. Any prior movement disorder treatments that involved intracranial surgery or device implantation.
  5. A history of neurostimulation intolerance in any area of the body.
  6. Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
  7. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
  8. Pregnancy, breast-feeding, or lack of reliable contraception

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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