Stimulation of the Rostral Zona Incerta for Parkinson's Disease

May 10, 2024 updated by: University of Colorado, Denver

Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Clinical Efficacy and Evaluation of Adverse Effects

Patients with Parkinson's Disease who undergo Deep Brain Stimulation surgery receive symptom relief due to electrical stimulation of the brain. The target for the stimulation, in many cases, is the subthalamic nucleus (STN). The brain area just above the STN is called the rostral Zona Incerta (rZI). The rZI may be a potential target for deep brain stimulation, in combination with the STN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Deep brain stimulation (DBS) of an area of the brain called the subthalamic nucleus (STN) is an effective treatment in Parkinson's disease (PD). However, stimulating the STN can lead to unwanted side effects that involve muscle movements (dyskinesias) and behavior and mood problems. DBS of a different brain structure, called the rostral zona incerta (rZI), has been demonstrated to be as effective as stimulating the STN, without any unwanted side effects in several studies. However, there is great variability in reported efficacy and adverse effects of rZI stimulation likely due to challenges in locating this area in the brain. The goals of this study are 1) to develop an improved method for targeting the rZI 2) determine efficacy of rZI with STN stimulation compared with STN stimulation alone, 3) evaluate any stimulation adverse effects of combined stimulation of the rZI and STN.

Study Type

Interventional

Enrollment (Actual)

14

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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parkinson's Disease,
  • No current deep brain stimulating electrodes

Exclusion Criteria:

  • Other movement disorders,
  • Parkinson's Disease with already implanted electrode.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
STN Monopolar Stimulation
Device: Deep Brain Stimulation
Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.
Experimental: 2
rZI + STN stimulation
Device: Deep Brain Stimulation
Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor testing
Time Frame: 1 week
Blinded UPDRS testing
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyskinesias
Time Frame: 1 week
Unified Dyskinesia Rating Scale
1 week
Cognition
Time Frame: 1 week
Montreal Cognitive Assessment
1 week
Depression
Time Frame: 1 week
Hamilton Depression Rating Scale
1 week
Anxiety
Time Frame: 1 week
Hamilton Anxiety Rating Scale
1 week
Suicide
Time Frame: 1 week
Columbia Suicide Severity Ratting Scale
1 week
Non-motor features of Parkinson's disease
Time Frame: 1 week
Movement Disorder Society-UPDRS I
1 week
Motor aspects of daily living
Time Frame: 1 week
Movement Disorder Society-UPDRS II
1 week

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Drew S Kern, MD, University of Colorado, Denver

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 (Actual)

July 3, 2017

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

February 17, 2023

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1443

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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