Functional Connectivity Parkinson Disease
31. oktober 2019 oppdatert av: University of Colorado, Denver
Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease
In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.
The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
86
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Denver
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD Neurology clinic.
Controls will be recruited from spouses and from the community
Beskrivelse
Inclusion Criteria:
- English as their primary language
- Patients with Parkinson disease and healthy controls will be enrolled
- Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month
Exclusion Criteria:
- If unable to provide informed consent
- Pregnancy
- Excess of 300lbs
- Claustrophobia
- Metal in body
- Untreated neurological or psychiatric condition, who are delusional or have hallucinations, with cognitive impairment (MOCA<26), with a history of head injury sufficient to cause a concussion, or with significant systemic medical diseases (e.g. heart failure, liver failure, kidney failure, poorly controlled diabetes, etc.)
- Healthy control subjects will be excluded if taking any type of dopaminergic or anti-dopaminergic medication
- Subjects who are unable to demonstrate understanding of the study procedures and risks will be excluded
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Tremor Dominant PD
Volunteers with predominantly tremor-related motor symptoms of PD
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Postural Instability & Gait Difficulty PD
Volunteers with primarily walking & balance-related motor symptoms of PD.
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Healthy Controls
Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Tidsramme: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
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A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
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At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
|
|
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Tidsramme: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
|
At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
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Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
Tidsramme: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
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Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.
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At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Task-related whole-brain activations.
Tidsramme: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
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Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
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At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
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Task-related whole-brain activations.
Tidsramme: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
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At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
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Connectivity between other motor and non-motor brain regions during the tasks.
Tidsramme: At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
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Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.
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At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
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Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Tidsramme: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
|
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
|
At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
|
|
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Tidsramme: At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
|
At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Brian Berman, MD, MS, University of Colorado, Denver
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2011
Primær fullføring (Faktiske)
1. oktober 2017
Studiet fullført (Faktiske)
1. oktober 2017
Datoer for studieregistrering
Først innsendt
11. desember 2012
Først innsendt som oppfylte QC-kriteriene
21. februar 2013
Først lagt ut (Anslag)
26. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10-1311
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
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