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Clinical Trials/NCT05353517
NCT05353517
Recruiting
N/A

Non-invasive Assessment of Brain and Spinal Synaptic Plasticity in Patients Affected by Movement Disorders

Neuromed IRCCS1 site in 1 country50 target enrollmentDecember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Movement Disorders
Sponsor
Neuromed IRCCS
Enrollment
50
Locations
1
Primary Endpoint
Analysis of neurophysiologic measures
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The pathophysiological mechanisms underlying Movement Disorders, including Parkinson's disease, have been related to altered synaptic plasticity affecting several structures of the central nervous system. Although several previous neurophysiologic investigations have shown abnormal long-term potentiation and depression-like plasticity in M1, other regions crucially involved in motor planning and execution, including the spinal cord, have been studied less. Parkinson's disease arises from the progressive loss of dendritic spines followed by atrophy of specific cortical (i.e. M1) and subcortical structures (i.e. putamen). These structural changes are responsible for the main clinical features of PD such as bradykinesia and rigidity. The present research project aims to probe non-invasively the main pathophysiologic mechanisms underlying altered synaptic plasticity in M1 and spinal cord and their relationship in a cohort of patients with movement disorders, including Parkinson's disease. More in detail, the investigators will use specific methodologies able to induce plasticity, including the repetitive transcranial magnetic stimulation (TMS), concerning the M1 and the focal muscle vibration, regarding the spinal cord. The neuromodulation protocol will imply 2 separate sessions, randomly scheduled to take into account the effect of the symptomatic pharmacologic treatment. Furthermore, patients will be randomly assigned to sham or real non-invasive stimulation groups. Before and after the stimulation protocol, the investigators will collect specific clinical as well as neurophysiologic measures (i.e., thresholds) according to standardized procedures. In conclusion, the goal of the study is to investigate the abnormal plasticity in the M1 and spinal cord in patients affected by specific movement disorders, through non-invasive techniques.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Neuromed IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Antonio Suppa

Prof, MD, PhD

Neuromed IRCCS

Eligibility Criteria

Inclusion Criteria

  • clinical diagnosis of Parkinson's disease

Exclusion Criteria

  • psychiatric disorders, including severe congnitive loss and depression

Outcomes

Primary Outcomes

Analysis of neurophysiologic measures

Time Frame: through study completion, an average of 1 year

input-output curve

Study Sites (1)

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