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Completed

NCT Number: NCT03212885

Stimulation of the Rostral Zona Incerta for Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Deep brain stimulation

Device

Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

Primary outcomes

  1. Motor testing

    Time frame: 1 week

    Blinded UPDRS testing

Secondary outcomes

  1. Dyskinesias

    Time frame: 1 week

    Unified Dyskinesia Rating Scale

  2. Cognition

    Time frame: 1 week

    Montreal Cognitive Assessment

  3. Depression

    Time frame: 1 week

    Hamilton Depression Rating Scale

  4. Anxiety

    Time frame: 1 week

    Hamilton Anxiety Rating Scale

  5. Suicide

    Time frame: 1 week

    Columbia Suicide Severity Ratting Scale

  6. Non-motor features of Parkinson's disease

    Time frame: 1 week

    Movement Disorder Society-UPDRS I

  7. Motor aspects of daily living

    Time frame: 1 week

    Movement Disorder Society-UPDRS II

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Jul 11, 2017
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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