NCT01575132

Brief Summary

The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. We wish to examine the effect of stimulation on motor symptoms as well as make a follow-up on complications and side-effects related to treatment. We also wish to follow-up on the quality of life-studies made in the years 2003-2008.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 10, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 11, 2013

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

April 10, 2012

Last Update Submit

December 10, 2013

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseStimulation, Deep BrainStudy, Follow-UpAdverse Effects

Study Arms (1)

Parkinson's Disease, DBS, 10-14 years

Eligibility Criteria

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

All Parkinson-patients treated with Deep Brain Stimulation at Aarhus University Hospital in the years 1998-2002.

You may qualify if:

  • Patients with Parkinson's Disease treated with DBS at Aarhus University Hospital in the years 1998-2002.

You may not qualify if:

  • Dementia, i.e. MMSE\<24
  • DBS removed
  • Deceased

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Neurology

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Karen Ostergaard, DMSci, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 11, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

September 1, 2015

Last Updated

December 11, 2013

Record last verified: 2012-11

Locations

DK(1)