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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01975532
First received: October 22, 2013
Last updated: December 4, 2015
Last verified: December 2015
  Purpose
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.

Condition
Movement Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive scores on neuropsychological exam [ Time Frame: patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients screened and deemed eligible for treatment with Deep Brain Stimulation
Criteria

Inclusion Criteria:

  • Deep Brian Stimulation surgery

Exclusion Criteria:

  • DBS treatment stopped before 12 month followup
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975532

Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Mikkel Petersen, phd-student Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01975532     History of Changes
Other Study ID Numbers: 26-MRI-DTI-on-DBS 
Study First Received: October 22, 2013
Last Updated: December 4, 2015
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 25, 2016