- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01798563
Functional Connectivity Parkinson Disease
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)
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Colorado
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Aurora, Colorado, Egyesült Államok, 80045
- University of Colorado Denver
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: Case-Control
- Időperspektívák: Leendő
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Időkeret: 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.
Időkeret: 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).
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Task-related whole-brain activations.
Időkeret: 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.
Időkeret: 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.
Időkeret: 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
Időkeret: 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.
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Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Időkeret: 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 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 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Brian Berman, MD, MS, University of Colorado, Denver
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 10-1311
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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