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

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ClinicalTrials.gov Identifier: NCT01563341
Recruitment Status : Unknown
Verified April 2013 by Ryan Uitti, Mayo Clinic.
Recruitment status was:  Enrolling by invitation
First Posted : March 26, 2012
Last Update Posted : April 25, 2013
Sponsor:
Information provided by (Responsible Party):
Ryan Uitti, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Deep Brain Stimulation Device: Deep brain stimulation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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).


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


Information from the National Library of Medicine

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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

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

Responsible Party: Ryan Uitti, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01563341     History of Changes
Other Study ID Numbers: 11-007086
First Posted: March 26, 2012    Key Record Dates
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