Clinical Outcomes for Deep Brain Stimulation | NCT03992625

Studies
Clinical Outcomes for Deep Brain Stimulation

NCT03992625

Sponsor

Washington University School of Medicine

Status

Recruiting

Last Update Posted

Jun 20, 2019Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Parkinson Disease
Essential Tremor
Dystonia

Interventions

Deep Brain Stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Link
R01NS075321	U.S. NIH Grant/Contract	View source
R01NS097437	U.S. NIH Grant/Contract	View source
R21NS098020	U.S. NIH Grant/Contract	View source
T32EB021955	U.S. NIH Grant/Contract	View source

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2011Actual

Primary Completion Date

Jan 1, 2030Estimated

Completion Date

Jan 1, 2030Estimated

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 19, 2019

First Posted Date

Jun 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2019

Last Update Posted Date

Jun 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mwiza Ushe, Assistant Professor, Washington University School of MedicinePrincipal Investigator

Lead Sponsor

Washington University School of MedicineOTHER

Collaborators

Name	Class
National Institute for Biomedical Imaging and Bioengineering (NIBIB)	NIH
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep Brain Stimulation	Device	High frequency electrical stimulation of deep brain nuclei for the treatment of movement disorders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UPDRS	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.	Change in UPDRS at 1 year after DBS (from preoperative baseline).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Levodopa responsive Parkinson disease OR
Medically refractory Essential Tremor OR
Medically refractory Dystonia

Exclusion Criteria:

Dementia (Mattis Dementia Rating Scale <130)
Structural abnormalities precluding intracranial surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving deep brain stimulation for movement disorders

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mwiza Ushe, M.D.	Contact	3143625262		ushem@wustl.edu

Overall Officials

Name	Affiliation	Role
Mwiza Ushe, M.D.	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University in St Louis	Recruiting	St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020329	Essential Tremor
D004421	Dystonia

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046690	Deep Brain Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided