NCT03212885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

4.6 years

First QC Date

July 7, 2017

Last Update Submit

May 10, 2024

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Motor testing

    Blinded UPDRS testing

    1 week

Secondary Outcomes (7)

  • Dyskinesias

    1 week

  • Cognition

    1 week

  • Depression

    1 week

  • Anxiety

    1 week

  • Suicide

    1 week

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

STN Monopolar Stimulation

Device: Deep Brain Stimulation

2

EXPERIMENTAL

rZI + STN stimulation

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Drew S Kern, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

July 3, 2017

Primary Completion

January 31, 2022

Study Completion

February 17, 2023

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)