DAT SPECT and Procedural Motor Skills in Parkinson's Disease

NCT03076307 | Completed

• 1 other identifier: CCER 2016-01469
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Resting state EEG connectivity in PD and control groups

  2 days

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

  2 days

Study Arms (2)

Parkinson's disease

EXPERIMENTAL

Behavioral: Procedural Motor Skills with mirror-drawing of figures

Control group

ACTIVE COMPARATOR

Behavioral: Procedural Motor Skills with mirror-drawing of figures

Interventions

Procedural Motor Skills with mirror-drawing of figures BEHAVIORAL

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

Control group; Parkinson's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 year-old
• Diagnosis of PD with onset \<2 years from enrollment
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Division of Neurorehabilitation, Geneva University Hospitals

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Med. Nicolas NICASTRO

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: October 18, 2016
• Primary Completion: May 20, 2017
• Study Completion: July 19, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)