- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03076307
DAT SPECT and Procedural Motor Skills in Parkinson's Disease
Correlation of Procedural Motor Skills Impairment and 123I-FP-CIT SPECT Uptake in Patients With Early Parkinson's Disease: a Case-control Study
Patients with Parkinson's disease (PD) are known to be affected by subtle cognitive impairment early in the disease course, mostly in the executive field. Procedural motor skills, mainly controlled by the basal ganglia associative loop (in particular dorsal caudate nucleus) (Rodriguez-Oroz et al., 2009), have also been studied in patients with PD (Schnider et al., 1995; Muslimovic et al., 2007; Terpening et al., 2013). However, the correlation of dopaminergic 123I-FP-CIT SPECT imaging and cognitive impairment has not been assessed. One reason is the absence of reference values for striatal uptake until recently. Last year, the investigators established local uptake reference values for DAT imaging based on a large cohort of subjects with non-degenerative conditions (Nicastro et al., 2016) and can therefore use these values to precisely assess uptake loss in patients with PD.
With the present study, the investigators expect to enroll patients with early PD for whom a 123I-FP-CIT SPECT has been previously performed in the center. Subjects will perform a specific motor task based on mirror-drawing of star-shaped figures. This will be done by inverting the direction of horizontal/vertical computer mouse movements on the screen. Speed and error rates will be assessed for patients as well as healthy control subjects. Correlation with striatal SPECT uptake, especially caudate nucleus uptake, will be analyzed for PD patients. In addition, resting-state EEG will be performed for all subjects. General medication and dopaminergic drugs in particular, whenever used, will not be discontinued. For all subjects enrolled in the study, cognitive and neurological examination will be performed.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Geneva, Schweiz, 1206
- Division of Neurorehabilitation, Geneva University Hospitals
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion criteria for PD group:
- Age > 18 year-old
- Diagnosis of PD with onset <2 years from enrollment
- Available DAT SPECT performed in Geneva University Hospitals <6 months before inclusion
Inclusion criteria for control group:
Age- and sex-matched control patients
- Age > 18 year-old
- No known neurological condition interfering with motor and cognitive abilities
- No medication interfering with central nervous system (including antidepressants, antipsychotics, hypnotics)
Exclusion criteria for both groups:
- Major depressive state (Hospital Anxiety and Depression scale ≥11 for depression score)
- Cognitive decline (Mini-Mental Score ≤ 22/30)
- Debilitating tremor (Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - rest, postural and action tremor ≥2/4)
- Significant akinesia (MDS-UPDRS III hand brady-akinesia score ≥2/4)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kontrollgrupp
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Evaluation of error rate and speed for completion of a procedural motor task
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Experimentell: Parkinson's disease
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Evaluation of error rate and speed for completion of a procedural motor task
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procedural motor performance (error and time) in PD group
Tidsram: 2 days
|
Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures
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2 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Resting state EEG connectivity in PD and control groups
Tidsram: 2 days
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Evaluation of resting state EEG connectivity in both groups
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2 days
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Difference >20% in error rate and speed improvement in control and PD groups
Tidsram: 2 days
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Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials
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2 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CCER 2016-01469
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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