NCT01210781

Brief Summary

Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement. The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

  • Trial with surgical intervention

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 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

Study Start

First participant enrolled

September 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

16.3 years

First QC Date

September 27, 2010

Last Update Submit

November 30, 2023

Conditions

Movement DisordersEpilepsy

Keywords

All indication for deep brain stimulation (DBS)

Outcome Measures

Primary Outcomes (1)

  • neurological outcome

    UPDRS

    5 years

Interventions

deep brain stimulation (DBS)PROCEDURE

deep brain stimulation (DBS) is in itself not part of this study but a clinical indication. The study aims at documenting DBS parameters and outcome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive patients implanted with DBS electrodes at our institution

You may qualify if:

  • Patients fullfill all criteria for implantation of deep brain stimulation (DBS) electrodes
  • Patients are able to give informed written consent

You may not qualify if:

  • Patients do not their give informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Neurosurgery

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Movement DisordersEpilepsy

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesBrain Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Johannes Sarnthein, Prof Dr

    University Hospital Zurich, Division of Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

September 1, 2009

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations

CH(1)