Evaluation of Diffusion MRI as a Tool in Planning Deep Br... | NCT01975532

Studies
Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)

NCT01975532

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Dec 7, 2015Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Movement Disorders

Interventions

Not provided

Countries

Not provided

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

Dec 2015

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

Nov 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Oct 22, 2013

First Submission Date that Met QC Criteria

Oct 28, 2013

First Posted Date

Nov 4, 2013Estimated

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

Dec 4, 2015

Last Update Posted Date

Dec 7, 2015Estimated

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

The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.

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

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UPDRS (unified parkinson disease rating scale) score		patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months

Secondary Outcomes

Measure	Description	Time Frame
Cognitive scores on neuropsychological exam		patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Deep Brian Stimulation surgery

Exclusion Criteria:

DBS treatment stopped before 12 month followup

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

Patients screened and deemed eligible for treatment with Deep Brain Stimulation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mikkel Petersen, phd-student	Aarhus University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009069	Movement Disorders

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided