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Stimulation of the Rostral Zona Incerta for Parkinson's Disease

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: Deep Brain Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03212885
16-1443

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

14 participants in 2 patient groups

1
Experimental group
Description:
STN Monopolar Stimulation
Treatment:
Device: Deep Brain Stimulation
2
Experimental group
Description:
rZI + STN stimulation
Treatment:
Device: Deep Brain Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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