Parkinson Disease
Conditions
Brief summary
The goal of this trial is to evaluate the preliminary safety and efficacy of programming to maximize stimulation of the dorsolateral region of the subthalamic nucleus (STN) receiving primary motor (M1) and supplementary motor area (SMA), but not pre-SMA, input deep brain stimulation (DBS) in patients with early-stage Parkinson's disease (PD).
Interventions
DEVICEactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy
DEVICEinactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
optimal drug therapy alone with DBS device turned off
Sponsors
Mallory Hacker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
motor scores will be blindly rated by an independent movement disorders neurologist who will be unaware of treatment assignment, ON vs OFF treatment status, or visit sequence
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. A clinical diagnosis of idiopathic Parkinson's disease (PD). The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia. 2. Clear and dramatic beneficial response to dopaminergic therapy, defined as ≥30% in UPDRS III with administration of the patient's medication during the screening neurological examination. 3. Hoehn and Yahr (H\&Y) stage II when OFF medication. 4. No contraindications to surgery (i.e., subject does not have uncontrollable medical or psychiatric illness;
Exclusion criteria
). 5. Age between 50 and 75 years old. 6. Dopaminergic therapy for greater than one year and less than four years. 7. Available for follow-up for the entire duration of the study. 8. Informed Consent (Appendix C): The subject is willing and able to provide written informed consent. 9. MRI within normal range (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frequency and severity of adverse events | 24 months | frequency and severity of adverse events |
| frequency and severity of adverse cognitive outcome | 24 months | decline from baseline at ≥ 1.5 SD (modest) and ≥ 2.0 (substantial) in tests comprising a comprehensive neuropsychological battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stopped or Reversed Motor Progression | 24 months | compare changes in motor progression for active DBS+ODT vs inactive DBS+ODT |
Contacts
CONTACTMallory Hacker, PhD, MSCI
Outcome results
None listed