NCT01909531

Brief Summary

The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

10.8 years

First QC Date

July 24, 2013

Last Update Submit

September 14, 2021

Conditions

Parkinson's DiseaseEssential Tremor

Keywords

Deep Brain StimulationParkinsons DiseaseEssential TremorAsleep DBS

Outcome Measures

Primary Outcomes (1)

  • Data Comparison

    Data comparison for pre-operative testing, diagnosis, surgical treatment, target accuracy, complications and outcomes for patients undergoing DBS surgery will be analyzed.

    Pre-operative through 6 months post operative

Secondary Outcomes (1)

  • Quantitative Evaluation of Balance and Gait

    Pre-operative through 6 months post-operative

Other Outcomes (1)

  • Quantitative Evaluation of Saccadic Eye Movements

    Pre-operartive - 6 months post-operative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's Disease or Essential Tremor who have undergone either awake or asleep DBS surgery performed by Francisco A. Ponce, MD

You may qualify if:

  • Clinical diagnosis for Parkinson's Disease or Essential Tremor
  • Subject has undergone DBS surgery

You may not qualify if:

  • Clinical diagnosis for Parkinson's Disease or Essential Tremor
  • Subject has not undergone DBS surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital & Medical Center / Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseEssential Tremor

Condition Hierarchy (Ancestors)

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

Study Officials

  • Francisco A Ponce, MD

    St. Joseph's Hospital & Medical Center / Barrow Neurological Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

April 1, 2013

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

US(1)