- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905995
Basal Ganglia Local Field Potentials in Gait and Speech
July 22, 2013 updated by: Kai Bötzel
Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Munich/München, Germany
- Recruiting
- Dept. of Neurology, Ludwig-Maximilians University of Munich
-
Contact:
- Kai Bötzel, M.D.
- Phone Number: 0049 89 7095 3673
- Email: kboetzel@med.uni-muenchen.de
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Principal Investigator:
- Kai Bötzel, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with advanced Parkinson's disease
Description
Inclusion Criteria:
- good levodopa response
Exclusion Criteria:
- dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Patients with advanced Parkinson's disease
no intervention - observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference of frequency spectrum of basal ganglia local field potentials during gait and speech
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence for the benefit of different stimulator settings for gait and speech
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kai Bötzel, M.D., Ludwig-Maximilians - University of Munich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 19, 2013
First Submitted That Met QC Criteria
July 22, 2013
First Posted (Estimate)
July 23, 2013
Study Record Updates
Last Update Posted (Estimate)
July 23, 2013
Last Update Submitted That Met QC Criteria
July 22, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BG EEG Munich
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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