Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.
GUIDE XT may be used for planning of programming as needed.
Age
22–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of bilateral idiopathic PD (H\&Y ≥ 2) with a duration of PD ≥ 5 years.
Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
You may not be if
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
Any other active implanted devices including neurostimulators and /or drug delivery pumps
Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
