Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation
Brief summary
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
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.
Interventions
DEVICEDeep Brain Stimulation
Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Parkinson's Disease, * No current deep brain stimulating electrodes
Exclusion criteria
* Other movement disorders, * Parkinson's Disease with already implanted electrode.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor testing | 1 week | Blinded UPDRS testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognition | 1 week | Montreal Cognitive Assessment |
| Depression | 1 week | Hamilton Depression Rating Scale |
| Anxiety | 1 week | Hamilton Anxiety Rating Scale |
| Dyskinesias | 1 week | Unified Dyskinesia Rating Scale |
| Non-motor features of Parkinson's disease | 1 week | Movement Disorder Society-UPDRS I |
| Motor aspects of daily living | 1 week | Movement Disorder Society-UPDRS II |
| Suicide | 1 week | Columbia Suicide Severity Ratting Scale |
Countries
United States
Outcome results
None listed