Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Scientific Corporation
About this trial
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be previously treated with or eligible for implantation with a deep brain stimulation system
Disqualifiers
No Exclusion Criteria
Trial population
Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Deep Brain Stimulation
DeviceDeep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
Treatment groups
5,000 Participants
are divided into 3 treatment groupsGroup A: Parkinson's Disease1 intervention
Group B: Essential Tremor1 intervention
Group C: Dystonia1 intervention
Trial outcomes
Primary outcomes
1
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline
Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline
Time frame
5 yrs. post implantSponsors and contacts
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Source ClinicalTrials.gov