Stimulation of the Rostral Zona Incerta for Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's Disease, No current deep brain stimulating electrodes Exclusion Criteria: Other movement disorders, Parkinson's Disease with already implanted electrode.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor testing | Blinded UPDRS testing | 1 week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation