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

May 11, 2023 updated by: Ryan Uitti, Mayo Clinic
Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ryan Uitti, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-007086

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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