Basal Ganglia Local Field Potentials in Gait and Speech | NCT01905995

Studies
Basal Ganglia Local Field Potentials in Gait and Speech

NCT01905995

Sponsor

Kai Bötzel

Status

Unknown status

Last Update Posted

Jul 23, 2013Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Basal Ganglia Diseases

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 19, 2013

First Submission Date that Met QC Criteria

Jul 22, 2013

First Posted Date

Jul 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2013

Last Update Posted Date

Jul 23, 2013Estimated

Name	Class
Medtronic	INDUSTRY
Lueneburg Heritage	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with advanced Parkinson's disease		no intervention - observational study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference of frequency spectrum of basal ganglia local field potentials during gait and speech		1 year

Secondary Outcomes

Measure	Description	Time Frame
Evidence for the benefit of different stimulator settings for gait and speech		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good levodopa response

Exclusion Criteria:

dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced Parkinson's disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai Boetzel, M.D	Contact	00498970953673		kboetzel@med.uni-muenchen.de

Overall Officials

Name	Affiliation	Role
Kai Bötzel, M.D.	Ludwig-Maximilians - University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Neurology, Ludwig-Maximilians University of Munich	Recruiting	Munich/München			Germany

Condition Browse Module

MeSH Terms

ID	Term
D001480	Basal Ganglia Diseases

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided