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DAT SPECT and Procedural Motor Skills in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03076307
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Nicolas Nicastro, University Hospital, Geneva

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Procedural Motor Skills with mirror-drawing of figures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
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
Actual Study Start Date : October 18, 2016
Actual Primary Completion Date : May 20, 2017
Actual Study Completion Date : July 19, 2017


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076307


Locations
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Switzerland
Division of Neurorehabilitation, Geneva University Hospitals
Geneva, Switzerland, 1206
Sponsors and Collaborators
University Hospital, Geneva

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Responsible Party: Nicolas Nicastro, Dr. Med. Nicolas NICASTRO, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03076307     History of Changes
Other Study ID Numbers: CCER 2016-01469
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases