Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Ryan Uitti, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01563341

First received: March 20, 2012

Last updated: April 24, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 20, 2012

Last Updated Date

April 24, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in memory testing from presurgical baseline to 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01563341 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation

Official Title ^ICMJE

Tandem DBS for Parkinson&Apos;s Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation

Brief Summary

Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson's Disease
Deep Brain Stimulation

Intervention ^ICMJE

Device: Deep brain stimulation

Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients will be enrolled from the practice of the primary investigator.
PD patients in whom optimal medical therapy has failed.
All patients will have responsivity to levodopa.
Individuals with normal or mild cognitive impairment.

Exclusion Criteria:

Clinically significant dementia
Other significant neurological or psychiatric disease
Previous brain surgery including pallidotomy or thalamotomy
Previous placement of other implantable devices

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01563341

Other Study ID Numbers ^ICMJE

11-007086

Has Data Monitoring Committee

Responsible Party

Ryan Uitti, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ryan Uitti, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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