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

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.
 
ClinicalTrials.gov Identifier: NCT01563341
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2012
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ryan Uitti, Mayo Clinic

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Study Start Date : April 2012
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Change in memory testing from presurgical baseline to 12 months [ Time Frame: baseline, 12 months ]
    Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered, in any order. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as "improved" and a negative direction of change would be interpreted as "declined".


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

Inclusion Criteria:

  • All patients will be enrolled from the practice of the primary investigator.
  • Parkinson's Disease (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
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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
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ryan Uitti, M.D. Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Ryan Uitti, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01563341    
Other Study ID Numbers: 11-007086
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases