DAT SPECT and Procedural Motor Skills in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Procedural Motor Skills with mirror-drawing of figures
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease
Eligibility Criteria
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)
Sites / Locations
- Division of Neurorehabilitation, Geneva University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parkinson's disease
Control group
Arm Description
Outcomes
Primary Outcome Measures
Procedural motor performance (error and time) in PD group
Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures
Secondary Outcome Measures
Resting state EEG connectivity in PD and control groups
Evaluation of resting state EEG connectivity in both groups
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
Full Information
NCT ID
NCT03076307
First Posted
March 6, 2017
Last Updated
July 19, 2017
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT03076307
Brief Title
DAT SPECT and Procedural Motor Skills in Parkinson's Disease
Official Title
Correlation of Procedural Motor Skills Impairment and 123I-FP-CIT SPECT Uptake in Patients With Early Parkinson's Disease: a Case-control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 18, 2016 (Actual)
Primary Completion Date
May 20, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinson's disease
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Procedural Motor Skills with mirror-drawing of figures
Intervention Description
Evaluation of error rate and speed for completion of a procedural motor task
Primary Outcome Measure Information:
Title
Procedural motor performance (error and time) in PD group
Description
Evaluation of error rate and speed for completion of mirror-drawing of star-shaped figures
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Resting state EEG connectivity in PD and control groups
Description
Evaluation of resting state EEG connectivity in both groups
Time Frame
2 days
Title
Difference >20% in error rate and speed improvement in control and PD groups
Description
Evaluation of a >20%-difference between PD and control groups in terms of speed and error rate for the successive procedural motor task trials
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Division of Neurorehabilitation, Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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DAT SPECT and Procedural Motor Skills in Parkinson's Disease
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