Stimulation of the Rostral Zona Incerta for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212885
• Other study ID #: 16-1443
• Status: Completed
• Phase: N/A
• Start date: July 3, 2017
• Est. completion date: February 17, 2023

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 17, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Parkinson's Disease,

• No current deep brain stimulating electrodes

Exclusion Criteria:

• Other movement disorders,

• Parkinson's Disease with already implanted electrode.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Deep Brain Stimulation
Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor testing	Blinded UPDRS testing	1 week
Secondary	Dyskinesias	Unified Dyskinesia Rating Scale	1 week
Secondary	Cognition	Montreal Cognitive Assessment	1 week
Secondary	Depression	Hamilton Depression Rating Scale	1 week
Secondary	Anxiety	Hamilton Anxiety Rating Scale	1 week
Secondary	Suicide	Columbia Suicide Severity Ratting Scale	1 week
Secondary	Non-motor features of Parkinson's disease	Movement Disorder Society-UPDRS I	1 week
Secondary	Motor aspects of daily living	Movement Disorder Society-UPDRS II	1 week