Essential TremorPHENONCT02132052
Defining Phenotypes of Movement Disorders :Parkinson's Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography.
An observational study of Essential Tremor and Multiple System Atrophy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Essential Tremor, Multiple System Atrophy, Corticobasal Degeneration
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University of Colorado Hospital Movement Disorders Clinic Patients
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Colorado. Denver, MEG Lab
Aurora, Colorado, 80045
About this study
Official title: Defining Cognitive and Motor Phenotypes of Parkinson's Disease (PD) With Magnetoencephalography
Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans.
Read the detailed description
Specific Aim 1: Determine which features of resting Magnetoencephalography (MEG) brain activity most sensitively discriminate between PD with normal cognition, PD with mild cognitive impairment (MCI), and PD dementia (PDD). Investigators predict that frontal network slowing and connectivity will discriminate between normal cognition and MCI while visuospatial network involvement will distinguish the PDD group.
Specific Aim 2: Determine which features of resting MEG brain activity most sensitively discriminate PDD from Alzheimer's Disease. Investigators predict that PDD will be distinguished from Alzheimer's (AD) on the basis of increased network connectivity, particularly in frontal and visuospatial networks.
Specific Aim 3 Investigate how resting state MEG activity correlates with task related brain activity. Investigators predict that resting state slowing will be associated with decreased task related brain activity.
Specific Aim 4: Determine which features of resting MEG brain activity most sensitively discriminate between motor subtypes of PD and also other relevant clinical populations (essential tremor and Parkinson plus syndromes). Investigators predict that frontal and parietal slowing and connectivity will discriminate PD from related conditions and that patterns of motor cortex connectivity and activity will differentiate among PD motor phenotypes.
- Conditions
- Essential Tremor, Multiple System Atrophy, Corticobasal Degeneration, Supranuclear Palsy, Progressive, Parkinson Disease
- Keywords
- Essential Tremor, Multiple System Atrophy, Corticobasal Degeneration, Supranuclear Palsy, Progressive, Parkinson's Disease, PD
- Medical subject headings
- Essential Tremor, Multiple System Atrophy, Corticobasal Degeneration, Supranuclear Palsy, Progressive, Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: May 2014
Secondary outcomes (4)
Spectral coherence:
- Spectral coherence: Coherence is a measure of interdependence between two time series and can be applied to MEG data to determine functional networks.4a-chen Coherence will be derived from the autoregressive models.
Measured: May 2014
Spectral Granger analysis:
- Spectral Granger analysis: Granger analysis is a measure of the directionality of the relationship of two time series and can be applied to sensors or sources found to have significant coherence.
Measured: May 2014
Reactivity:
Reactivity: Reactivity refers to changes in oscillatory activity between the eye open and eye closed conditions. Prior research in AD has shown significantly reduced reactivity compared to age-matched controls.
Measured: May 2014
Complex network analysis:
Complex network analysis: Complex network analysis, originally developed in graph theory, is an approach to the study of complex systems such as brain networks. It allows investigators to characterize brain networks with a small number of neurobiologically meaningful and easily computable measures, including transitivity, global efficiency, and betweenness. These measures will be used to reveal the hypothesized connectivity abnormalities in PD and to differentiate different cognitive phenotypes in PD.
Measured: May 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- benzi Kluger, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132052
- Sponsor's protocol ID
- 11-0952
- Acronym
- PHENO
- Status last verified
- Jun 2021
- First submitted
- 2 May 2014
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Cognitive and Motor Phenotypes of Parkinson's Disease (PD) With Magnetoencephalography
- ClinicalTrials.gov ID
- NCT02132052
- Acronym / sponsor ID
- PHENO / 11-0952
- Conditions
- Essential Tremor, Multiple System Atrophy, Corticobasal Degeneration, Supranuclear Palsy, Progressive, Parkinson Disease
- Keywords
- Essential Tremor, Multiple System Atrophy, Corticobasal Degeneration, Supranuclear Palsy, Progressive, Parkinson's Disease, PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators hypothesize that there are specific characteristic of each cognitive and motor condition that can be defined using brains scans.
Detailed description
Specific Aim 1: Determine which features of resting Magnetoencephalography (MEG) brain activity most sensitively discriminate between PD with normal cognition, PD with mild cognitive impairment (MCI), and PD dementia (PDD). Investigators predict that frontal network slowing and connectivity will discriminate between normal cognition and MCI while visuospatial network involvement will distinguish the PDD group.
Specific Aim 2: Determine which features of resting MEG brain activity most sensitively discriminate PDD from Alzheimer's Disease. Investigators predict that PDD will be distinguished from Alzheimer's (AD) on the basis of increased network connectivity, particularly in frontal and visuospatial networks.
Specific Aim 3 Investigate how resting state MEG activity correlates with task related brain activity. Investigators predict that resting state slowing will be associated with decreased task related brain activity.
Specific Aim 4: Determine which features of resting MEG brain activity most sensitively discriminate between motor subtypes of PD and also other relevant clinical populations (essential tremor and Parkinson plus syndromes). Investigators predict that frontal and parietal slowing and connectivity will discriminate PD from related conditions and that patterns of motor cortex connectivity and activity will differentiate among PD motor phenotypes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Colorado Hospital Movement Disorders Clinic Patients
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Focal oscillatory activity
Time frame: May 2014
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.
4 secondary outcomes
Spectral coherence:
Time frame: May 2014
Spectral Granger analysis:
Time frame: May 2014
Reactivity:
Time frame: May 2014
Complex network analysis:
Time frame: May 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
benzi Kluger, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Multiple System Atrophy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focal oscillatory activity (time frame: May 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.