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NCT Number: NCT03076307

DAT SPECT and Procedural Motor Skills in Parkinson's Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Neurorehabilitation, Geneva University Hospitals

Geneva, 1206, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Procedural Motor Skills with mirror-drawing of figures

Behavioral

Evaluation of error rate and speed for completion of a procedural motor task

Primary outcomes

  1. Procedural motor performance (error and time) in PD group

    Time frame: 2 days

    Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures

Secondary outcomes

  1. Resting state EEG connectivity in PD and control groups

    Time frame: 2 days

    Evaluation of resting state EEG connectivity in both groups

  2. Difference >20% in error rate and speed improvement in control and PD groups

    Time frame: 2 days

    Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Correlation of Procedural Motor Skills Impairment and 123I-FP-CIT SPECT Uptake in Patients With Early Parkinson's Disease: a Case-control Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2017
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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