NCT01905995

Brief Summary

Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc). Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

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

Study Start

First participant enrolled

July 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

1.4 years

First QC Date

July 19, 2013

Last Update Submit

July 22, 2013

Conditions

Basal Ganglia Diseases

Keywords

deep brain sitimulationlocal field potentials

Outcome Measures

Primary Outcomes (1)

  • Difference of frequency spectrum of basal ganglia local field potentials during gait and speech

    1 year

Secondary Outcomes (1)

  • Evidence for the benefit of different stimulator settings for gait and speech

    one year

Study Arms (1)

Patients with advanced Parkinson's disease

no intervention - observational study

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with advanced Parkinson's disease

You may qualify if:

  • good levodopa response

You may not qualify if:

  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, Ludwig-Maximilians University of Munich

Munich/München, Germany

RECRUITING

MeSH Terms

Conditions

Basal Ganglia Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kai Bötzel, M.D.

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Boetzel, M.D

CONTACT

00498970953673kboetzel@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 23, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

DE(1)