Ventrointermediate Nucleus (VIM DBS) and Working Memory | NCT00906412

Studies
Ventrointermediate Nucleus (VIM DBS) and Working Memory

NCT00906412

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Nov 10, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Essential Tremor

Interventions

Not provided

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

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Sep 2013Actual

Completion Date

Nov 2016Actual

First Submitted Date

May 19, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

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

Nov 9, 2016

Last Update Posted Date

Nov 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. We are especially trying to figure out how stimulation on each side of the brain may affect working memory.

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

Not provided

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ET Group		Total of 25 participants with ET
Controls		25 controls without ET

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ET PATIENTS:

Clinical diagnosis of essential tremor affecting the upper extremities.
Previous unilateral or bilateral DBS of the VIM
Ages 40 -70
A useable pre-surgical MR scan

CONTROLS:

Spouse or acquaintance of enrolled patient participant
Ages 40 - 70

Exclusion Criteria:

ET PATIENTS:

Clinical evidence of other neurological conditions
Significant psychiatric condition

CONTROLS:

Clinical evidence of other neurological conditions
Significant psychiatric condition

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Washington University School of Medicine Movement Disorder Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hershey Tamara, PhD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

This is a small pilot study and consent to share data was not obtained.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020329	Essential Tremor

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided