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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Ryan Uitti, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563341
First Posted: March 26, 2012
Last Update Posted: April 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ryan Uitti, Mayo Clinic
  Purpose
Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.

Condition Intervention Phase
Parkinson's Disease Deep Brain Stimulation Device: Deep brain stimulation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tandem DBS for Parkinson&Apos;s Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation

Resource links provided by NLM:


Further study details as provided by Ryan Uitti, Mayo Clinic:

Primary Outcome Measures:
  • Change in memory testing from presurgical baseline to 12 months. [ Time Frame: 12 months ]

Estimated Enrollment: 6
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01563341


Locations
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ryan Uitti, MD Mayo Clinic
  More Information

Responsible Party: Ryan Uitti, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01563341     History of Changes
Other Study ID Numbers: 11-007086
First Submitted: March 20, 2012
First Posted: March 26, 2012
Last Update Posted: April 25, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases