NCT03998787

Brief Summary

Parkinson's disease (PD) is characterized by bradykinesia, rigidity, and tremor. Several scientific pieces of evidence, based on the use of kinematic techniques, have allowed quantifying objectively the alterations of the voluntary movement in the different stages of the disease. In recent years, several studies using transcranial magnetic stimulation (TMS) techniques, have also shown abnormalities in neurophysiological parameters of the primary motor cortex (M1) in patients with MP, in particular, a reduction in cortical excitability and synaptic plasticity of M1. In addition to the central role played by a dopaminergic deficit in MP, recent evidence suggests a possible involvement of the neurotransmitter glutamatergic system. In the present monocentric observational study, the investigators propose to assess possible correlations between polymorphisms of metabotropic glutamate type 3 receptors (mGlu3), clinical evaluation scales, alterations of kinematic motion parameters and neurophysiological parameters of M1.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

June 14, 2019

Last Update Submit

February 24, 2020

Conditions

Keywords

Parkinson's diseaseNeurophysiology

Outcome Measures

Primary Outcomes (2)

  • Neurophysiological assessment of PD patients

    Kinematic analysis of movement (i.e. amplitude and velocity)

    1 hours

  • Neurophysiological assessment of PD patients

    Transcranial magnetic stimulation of primary motor cortex (i.e. aamplitude of motor evoked potentials)

    1 hour

Secondary Outcomes (1)

  • Genetic analysis

    5 minutes

Study Arms (2)

Patients with Parkinson's disease

Patients with Parkinson's disease

Other: Neurophysiological assessment

Healthy Subjects

Healthy subjects

Other: Neurophysiological assessment

Interventions

Kinematic analysis of movement and transcranial magnetic stimulation

Healthy SubjectsPatients with Parkinson's disease

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study involves the recruitment of 20 patients with Parkinson's disease, diagnosed according to current clinical criteria and 20 healthy control subjects. Patients with motor fluctuations and dyskinesia will be excluded. Recruitment of patients and control subjects will be carried out at the IRCCS NEUROMED Institute, Pozzilli (IS). All patients will undergo blood sampling to assess polymorphisms of metabotropic glutamate type 3 (mGlu3) receptors. All study participants will give informed consent to the experimental procedures, which will be approved by the local ethics committee and conducted in accordance with the Helsinki Declaration.

You may qualify if:

  • Clinical diagnosis of Parkinson's disease
  • Must be able to participate to the experimental session

You may not qualify if:

  • Controindications to transcranial magnetic stimulation.
  • Presence of dyskinesias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Movement DisordersParkinson Disease

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alfredo Berardelli

    IRCCS Neuromed

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pincipal Investigator

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 26, 2019

Study Start

March 1, 2020

Primary Completion

October 1, 2020

Study Completion

September 1, 2022

Last Updated

February 26, 2020

Record last verified: 2020-02