Deep Brain Stimulation (DBS) Retrospective Outcomes Study

Conditions

• Dystonia
• Essential Tremor
• Parkinson Disease

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Deep Brain Stimulation — DEVICE
  Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Study Details

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.

Key Dates

First listed

Sep 10, 2018

Start date

Mar 12, 2019

Status verified

Jul 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: Parkinson's Disease
  Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
• Arm: Essential Tremor
  Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System
• Arm: Dystonia
  Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System

Primary Outcome Measure

Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline [ Time Frame: 5 yrs. post implant ]

Central Contacts

• Cleo Mertz
  855-213-9890
  [email protected]
• Diane Keesey
  855-213-9890
  [email protected]

Locations (9)

Find similar trials in Phoenix, AZ

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