NCT01975532

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

October 22, 2013

Last Update Submit

December 4, 2015

Conditions

Movement Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Cognitive scores on neuropsychological exam

    patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients screened and deemed eligible for treatment with Deep Brain Stimulation

You may qualify if:

  • Deep Brian Stimulation surgery

You may not qualify if:

  • DBS treatment stopped before 12 month followup

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Mikkel Petersen, phd-student

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 4, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 7, 2015

Record last verified: 2015-12