NCT03079037

Brief Summary

This study will test the hypothesis that deep brain stimulation (DBS) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal DBS thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2023

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

4.6 years

First QC Date

February 24, 2017

Last Update Submit

April 15, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Measure local field potential (LFP) changes in subthalamic nucleus (STN) and globus pallidus (GP) in OFF and ON states of stimulation and medication

    Clinical ratings scales (MDS-UPDRS)

    2 days

Study Arms (1)

Stimulation

Traditional deep brain stimulation

Device: Stimulation

Interventions

StimulationDEVICE

Traditional deep brain stimulation

Stimulation

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's Disease (PD)

You may qualify if:

  • Diagnosis of idiopathic PD
  • DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.

You may not qualify if:

  • Other significant neurological disorder
  • History of dementia
  • Prior history of stereotactic neurosurgery
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael C. Park, MD/PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 14, 2017

Study Start

June 19, 2018

Primary Completion

January 29, 2023

Study Completion

January 29, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations

US(1)