Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
The objective of this clinical investigation is to characterize the clinical performance of
 Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming
 InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or
 essential tremor (ET).
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical
 investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.

 This clinical investigation will be conducted at up to 5 centers in the United States.

 Up to 40 patients will be enrolled in the study. Of these subjects, up to 20 will have PD and
 up to 20 will have ET. All patients will have received Infinity DBS systems prior to
 enrolling in the study.

 Subjects participating in this clinical investigation will be followed for 6 months. The
 expected duration of enrollment is 6 months. The total duration of the clinical investigation
 is expected to be 18 months. The primary and secondary endpoints will be evaluated when all
 subjects have completed their 6 month follow-up visits
INCLUSION CRITERIA

 Parkinson's disease patients:

 1. Patient must provide written informed consent prior to any clinical study related
 procedure.

 2. Patient is 18 to 80 years of age.

 3. Patient is diagnosed with Parkinson's disease for at least 4 years according to
 standard practice.

 4. Patient is willing to maintain a constant dose of anti-Parkinson's disease medication
 indicated as best medical management for at least 1 month prior to study enrollment.

 5. Patient is willing and able to comply with the follow-up schedule for the length of
 the study.

 6. Patient has been implanted with an 8-channel directional Infinity deep brain
 stimulation system in the subthalamic nucleus (STN) within the last 12 months.

 7. Patient has had stable deep brain stimulation programming settings for at least 1
 month prior to study enrollment.

 Essential tremor patients:

 1. Patient must provide written informed consent prior to any clinical study related
 procedure.

 2. Patient is 18 to 80 years of age.

 3. Patient is diagnosed with essential tremor for at least 4 years according to standard
 practice.

 4. Patient is willing to maintain a constant dose of anti-tremor medication indicated as
 best medical management for at least 1 month prior to study enrollment.

 5. Patient is willing and able to comply with the follow-up schedule for the length of
 the study.

 6. Patient has been implanted with an 8-channel directional Infinity deep brain
 stimulation system in the ventral intermediate (Vim) thalamus within the last 12
 months.

 7. Patient has had stable deep brain stimulation programming settings for at least 1
 month prior to study enrollment.

 EXCLUSION CRITERIA

 1. Individuals unable to make the decision to participate in a clinical investigation on
 their own.

 2. Patient is currently programmed with segmented electrodes, and cannot tolerate
 omnidirectional programming.

 3. Patient is being evaluated for a lead revision.

 4. Patient has untreated clinically significant depression.

 5. Patient has dementia that interferes with their ability to co-operate or comply with
 study requirements or comprehend the informed consent, as determined by the
 investigator.

 6. Patient abuses drugs or alcohol.

 7. Patient is currently enrolled or plans to enroll in another concurrent study that may
 confound the results of this clinical investigation.

 8. Patient has a confirmation of diagnosis of a terminal illness associated with survival
 <12 months.

 9. Presence of other anatomic or comorbid conditions, or other medical, social, or
 psychological conditions that, in the investigator's opinion, could limit the
 patient's ability to participate in the clinical study or to comply with follow-up
 requirements, or impact the scientific soundness of the clinical study results.

 10. Pregnant or nursing patients and those who plan pregnancy during the clinical study
 follow-up period.