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出境医 / 临床实验 / Clinical Outcomes for Deep Brain Stimulation
Clinical Outcomes for Deep Brain Stimulation
Study Description
Brief Summary:
The object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications.
| Condition or disease | Intervention/treatment |
|---|---|
| Parkinson Disease Essential Tremor Dystonia | Device: Deep Brain Stimulation |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Other |
| Time Perspective: | Retrospective |
| Official Title: | Clinical Outcomes for Deep Brain Stimulation for Parkinson Disease, Tremor, and Dystonia |
| Actual Study Start Date : | January 3, 2011 |
| Estimated Primary Completion Date : | January 1, 2030 |
| Estimated Study Completion Date : | January 1, 2030 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- UPDRS [ Time Frame: Change in UPDRS at 1 year after DBS (from preoperative baseline). ]United Parkinson's Disease Rating Scale (global assessment of motor, non-motor, and quality of life associated with symptoms of Parkinson disease). Total scores range from 0-199. Particular emphasis is paid to subsection 3 (motor), where scores range from 0-56.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 13, 2019 | ||||||
| First Posted Date | June 20, 2019 | ||||||
| Last Update Posted Date | June 20, 2019 | ||||||
| Actual Study Start Date | January 3, 2011 | ||||||
| Estimated Primary Completion Date | January 1, 2030 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
UPDRS [ Time Frame: Change in UPDRS at 1 year after DBS (from preoperative baseline). ] United Parkinson's Disease Rating Scale (global assessment of motor, non-motor, and quality of life associated with symptoms of Parkinson disease). Total scores range from 0-199. Particular emphasis is paid to subsection 3 (motor), where scores range from 0-56.
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Clinical Outcomes for Deep Brain Stimulation | ||||||
| Official Title | Clinical Outcomes for Deep Brain Stimulation for Parkinson Disease, Tremor, and Dystonia | ||||||
| Brief Summary | The object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Other Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | All patients receiving deep brain stimulation for movement disorders | ||||||
| Condition |
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| Intervention | Device: Deep Brain Stimulation
High frequency electrical stimulation of deep brain nuclei for the treatment of movement disorders
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
1000 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | January 1, 2030 | ||||||
| Estimated Primary Completion Date | January 1, 2030 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03992625 | ||||||
| Other Study ID Numbers | 201101744 R01NS075321 ( U.S. NIH Grant/Contract ) R01NS097437 ( U.S. NIH Grant/Contract ) R21NS098020 ( U.S. NIH Grant/Contract ) T32EB021955 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mwiza Ushe, Washington University School of Medicine | ||||||
| Study Sponsor | Washington University School of Medicine | ||||||
| Collaborators |
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| Investigators |
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| PRS Account | Washington University School of Medicine | ||||||
| Verification Date | June 2019 | ||||||
