NCT02132052

Brief Summary

Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 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

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

May 2, 2014

Last Update Submit

June 23, 2021

Conditions

Keywords

Essential TremorMultiple System AtrophyCorticobasal DegenerationSupranuclear Palsy, ProgressiveParkinson's DiseasePD

Outcome Measures

Primary Outcomes (1)

  • Focal oscillatory activity

    Focal oscillatory activity: Focal band power for delta (0.5-4Hz), theta (4-8 Hz), alpha (9- 13 Hz), low beta (13-20 Hz), high beta (20-30 Hz) and gamma (30-50 Hz) activity will be derived from the autoregressive models.

    May 2014

Secondary Outcomes (4)

  • Spectral coherence:

    May 2014

  • Spectral Granger analysis:

    May 2014

  • Reactivity:

    May 2014

  • Complex network analysis:

    May 2014

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

University of Colorado Hospital Movement Disorders Clinic Patients

You may qualify if:

  • All subjects will be age 40 or older,
  • Be on stable medications for at least 30 days
  • Montreal Cognitive Assessment (MOCA) of 26 or higher
  • Scores within 1.5 standard deviations of age-matched norms for all neuropsychological tests
  • Parkinson's Plus Disorders (PD) will be defined using United Kingdom (UK) Brain Bank Criteria.
  • PD dementia (PDD) will be defined using the Movement Disorder Task Force 2007 criteria and supported by scores less than 1.5 standard deviations of age-matched norms in at least two domains.
  • Probable Alzheimer's Disease (AD) will be defined using the National Institute on Aging-Alzheimer Association 2011 guidelines.
  • Parkinson's Plus Disorders (PD) with mild cognitive impairment (MCI) will be defined by history, MOCA of 21 or higher, at least one score less than 1.5 standard deviations of age-matched norms, and cannot meet diagnostic criteria for PDD.
  • Essential tremor and Parkinson plus syndromes (multiple systems atrophy, corticobasal degeneration, progressive supranuclear palsy) will be defined using previously published research criteria.19-22

You may not qualify if:

  • Features suggestive of other causes of parkinsonism/Parkinson-plus syndromes;
  • Features suggestive of other causes of dementia, including moderate to severe cerebrovascular disease by history, or imaging or history of major head trauma;
  • History of deep brain stimulation, ablation surgery, or other brain surgery;
  • Evidence for depression based on the Hospital Anxiety Depression Scale (score \> 11).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Colorado. Denver, MEG Lab

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Essential TremorMultiple System AtrophyCorticobasal DegenerationSupranuclear Palsy, ProgressiveParkinson Disease

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative DiseasesTauopathiesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian Disorders

Study Officials

  • benzi Kluger, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 6, 2014

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 25, 2021

Record last verified: 2021-06

Locations