NCT02034318

Brief Summary

The purpose of this research study is to learn about a possible association between cardiac denervation (the breaking down of nerves in the heart) and the development of fatigue in Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

5.8 years

First QC Date

December 11, 2013

Last Update Submit

March 8, 2015

Conditions

Parkinson's Disease

Keywords

FatigueCardiac Sympathetic DenervationParkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Comparison of cardiac uptake with fatigue severity score

    The purpose of this research study is to learn about a possible association between cardiac denervation (the breaking down of nerves in the heart) and the development of fatigue in Parkinson's disease (PD).

    six weeks

Eligibility Criteria

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

Elderly/aged Outpatients

You may qualify if:

  • Have been diagnosed with Parkinson's disease within the past 5 years
  • Have mild to moderate Parkinson's disease (H\&Y Stage ≤ 3)

You may not qualify if:

  • Are currently pregnant or lactating
  • Fulfill DSM IV TR criteria for major depression or dysthymia
  • Fulfill DSM criteria for generalized anxiety disorder or panic disorder
  • Are currently taking a medication known to affect 123I-mIBG uptake (See Appendix 1)
  • Have a history of previous relevant cardiac disease, or any clinically significant abnormalities on routine chest radiography, electrocardiography, or cardiac ultrasonography
  • Have active lung disease, including asthma, COPD, or pneumonia
  • Have diabetes mellitus
  • Have congestive heart failure
  • Have an active systemic infection
  • History of allergic reaction to radionuclide agent or have allergy to iodine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseFatigue

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carlos Singer, MD

Study Record Dates

First Submitted

December 11, 2013

First Posted

January 13, 2014

Study Start

March 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

US(1)