Stimulation of the Rostral Zona Incerta for Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT03212885
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2017-07-03
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Primary Completion: 2022-01-31
• Study Completion: 2023-02-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Deep Brain Stimulation	STN Monopolar Stimulation
2	Deep Brain Stimulation	rZI + STN stimulation

Primary Outcome Measures

Name	Time	Method
Motor testing	1 week	Blinded UPDRS testing

Secondary Outcome Measures

Name	Time	Method
Depression	1 week	Hamilton Depression Rating Scale
Dyskinesias	1 week	Unified Dyskinesia Rating Scale
Cognition	1 week	Montreal Cognitive Assessment
Anxiety	1 week	Hamilton Anxiety Rating Scale
Suicide	1 week	Columbia Suicide Severity Ratting 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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States