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

December 4, 2015 updated by: University of Aarhus

Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients screened and deemed eligible for treatment with Deep Brain Stimulation

Description

Inclusion Criteria:

  • Deep Brian Stimulation surgery

Exclusion Criteria:

  • DBS treatment stopped before 12 month followup

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Mikkel Petersen, phd-student, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (ESTIMATE)

November 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-MRI-DTI-on-DBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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