Functional Connectivity Parkinson Disease
31 oktober 2019 uppdaterad 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)
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
86
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Denver
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
50 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Tidsram: 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.
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Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Tidsram: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
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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 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).
Tidsram: 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.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Task-related whole-brain activations.
Tidsram: 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.
Tidsram: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
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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 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.
Tidsram: 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
Tidsram: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
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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.
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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
Tidsram: 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).
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Brian Berman, MD, MS, University of Colorado, Denver
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2011
Primärt slutförande (Faktisk)
1 oktober 2017
Avslutad studie (Faktisk)
1 oktober 2017
Studieregistreringsdatum
Först inskickad
11 december 2012
Först inskickad som uppfyllde QC-kriterierna
21 februari 2013
Första postat (Uppskatta)
26 februari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 oktober 2019
Senast verifierad
1 oktober 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-1311
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
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