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Basal Ganglia Local Field Potentials in Gait and Speech

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ClinicalTrials.gov Identifier: NCT01905995
Recruitment Status : Unknown
Verified July 2013 by Kai Bötzel, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : July 23, 2013
Last Update Posted : July 23, 2013
Sponsor:
Collaborators:
Medtronic
Lueneburg Heritage
Information provided by (Responsible Party):
Kai Bötzel, Ludwig-Maximilians - University of Munich

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.


Condition or disease
Basal Ganglia Diseases

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease
Study Start Date : July 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with advanced Parkinson's disease
no intervention - observational study



Primary Outcome Measures :
  1. Difference of frequency spectrum of basal ganglia local field potentials during gait and speech [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evidence for the benefit of different stimulator settings for gait and speech [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced Parkinson's disease
Criteria

Inclusion Criteria:

  • good levodopa response

Exclusion Criteria:

  • dementia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905995


Contacts
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Contact: Kai Boetzel, M.D 00498970953673 kboetzel@med.uni-muenchen.de

Locations
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Germany
Dept. of Neurology, Ludwig-Maximilians University of Munich Recruiting
Munich/München, Germany
Contact: Kai Bötzel, M.D.    0049 89 7095 3673    kboetzel@med.uni-muenchen.de   
Principal Investigator: Kai Bötzel, M.D.         
Sponsors and Collaborators
Kai Bötzel
Medtronic
Lueneburg Heritage
Investigators
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Principal Investigator: Kai Bötzel, M.D. Ludwig-Maximilians - University of Munich

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Responsible Party: Kai Bötzel, Professor Dr. med., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01905995     History of Changes
Other Study ID Numbers: BG EEG Munich
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Keywords provided by Kai Bötzel, Ludwig-Maximilians - University of Munich:
deep brain sitimulation
local field potentials
Additional relevant MeSH terms:
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Ganglion Cysts
Synovial Cyst
Basal Ganglia Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases