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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01975532
Other study ID # 26-MRI-DTI-on-DBS
Secondary ID
Status Completed
Phase N/A
First received October 22, 2013
Last updated December 4, 2015
Start date November 2013
Est. completion date June 2015

Study information

Verified date December 2015
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Deep Brian Stimulation surgery

Exclusion Criteria:

- DBS treatment stopped before 12 month followup

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Outcome

Type Measure Description Time frame Safety issue
Primary UPDRS (unified parkinson disease rating scale) score patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months No
Secondary Cognitive scores on neuropsychological exam patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months No
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