Parkinson Disease Clinical Trial
— BURSTOfficial title:
Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease: A Pilot Study of Tolerability and Efficacy
NCT number | NCT05753449 |
Other study ID # | 2022-234 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 24, 2022 |
Est. completion date | April 2025 |
This is a study to evaluate Deep brain stimulation (DBS) burst-type electrical stimulation programming verses standard DBS programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered. Burst type DBS may improve the efficacy and durability of DBS pulse generator.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | April 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Bilateral DBS-STN (subthalamic nucleus) target for idiopathic Parkinson's disease implanted minimum 6 months prior to the day of study enrollment - Stable DBS programming settings and Parkinson's disease medications defined as no changes to either within past 6 months - Comfortable using DBS controller to turn off device prior to study visits - Able to provide informed consent and complete follow-up visits Exclusion Criteria: - DBS technology other than Boston scientific Genus/Gevia - Unable to complete follow-up visits - DBS brain targets other than STN (subthalamic nucleus) - Signs of progressive cognitive decline |
Country | Name | City | State |
---|---|---|---|
United States | AHN Allegheny General Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score | To determine change in the UPDRS-III motor score in the medication OFF state with burst-type DBS programming in the acute setting (after 30 minutes) and then after 6 months and 12 months.
Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 56. A higher score means a worse outcome. |
12 months |
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