DAT SPECT and Procedural Motor Skills in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076307
• Other study ID #: CCER 2016-01469
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: July 19, 2017
• Start date: October 18, 2016
• Est. completion date: July 19, 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 19, 2017
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Procedural Motor Skills with mirror-drawing of figures
Evaluation of error rate and speed for completion of a procedural motor task

Locations

Country	Name	City	State
Switzerland	Division of Neurorehabilitation, Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Resting state EEG connectivity in PD and control groups	Evaluation of resting state EEG connectivity in both groups	2 days
Secondary	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