Basal Ganglia Local Field Potentials in Gait and Speech

Basal Ganglia Diseases Clinical Trial

Official title:

Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01905995
• Other study ID #: BG EEG Munich
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2013
• Last updated: July 22, 2013
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: Kai Boetzel, M.D
• Phone: 00498970953673
• Email: kboetzel[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Ethical Committee of the Medical Faculty of Ludwig-Maximilians Universität Munich: germany
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• good levodopa response

Exclusion Criteria:

• dementia

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Basal Ganglia Diseases

Locations

Country	Name	City	State
Germany	Dept. of Neurology, Ludwig-Maximilians University of Munich	Munich/München

Sponsors (3)

Lead Sponsor	Collaborator
Kai Bötzel	Lueneburg Heritage, Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of frequency spectrum of basal ganglia local field potentials during gait and speech		1 year	No
Secondary	Evidence for the benefit of different stimulator settings for gait and speech		one year	No