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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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Tandem
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ryan Uitti, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01563341     History of Changes
Other Study ID Numbers: 11-007086
Study First Received: March 20, 2012
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013