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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Procedural Motor Skills with mirror-drawing of figures

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • Division of Neurorehabilitation, Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: Procedural Motor Skills with mirror-drawing of figures; Evaluation of error rate and speed for completion of a procedural motor task
Experimental: Parkinson's disease	Behavioral: Procedural Motor Skills with mirror-drawing of figures; Evaluation of error rate and speed for completion of a procedural motor task

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural motor performance (error and time) in PD group	Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting state EEG connectivity in PD and control groups	Evaluation of resting state EEG connectivity in both groups	2 days
Difference >20% in error rate and speed improvement in control and PD groups	Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials	2 days

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): May 20, 2017
• Study Completion (Actual): July 19, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CCER 2016-01469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No