Non-invasive Assessment of Synaptic Plasticity (NEUROPLAST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Movement Disorders
• Intervention / Treatment: Device: Device: focal muscle vibration and theta burst stimulation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Antonio Suppa, MD, PhD; Phone Number: +0039 3494940365; Email: antonio.suppa@uniroma1.it
• Study Contact Backup: Name: Francesco Asci, MD; Phone Number: +0039 3488263444; Email: francesco.asci@uniroma1.it

Study Locations

• Italy
  • Pozzilli, Italy, 86077
    • Recruiting
    • IRCCS Neuromed
    • Contact: Antonio Suppa, MD; Phone Number: +00390649914074

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

25 patients with PD 25 HS

Description

Inclusion Criteria:

• clinical diagnosis of Parkinson's disease

Exclusion Criteria:

• psychiatric disorders, including severe congnitive loss and depression

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Subjects; Device: focal muscle vibration to induce spinal plasticity theta burst stimulation and paired associative stimulation to induce plasticity in M1	Device: Device: focal muscle vibration and theta burst stimulation; non invasive techniques of neuromodulation for inducing plasticity in M1 and spinal cord
Patients with Parkinson's disease; Device: theta burst stimulation and paired associative stimulation to induce plasticity in M1 Device: focal muscle vibration to induce spinal plasticity	Device: Device: focal muscle vibration and theta burst stimulation; non invasive techniques of neuromodulation for inducing plasticity in M1 and spinal cord

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of neurophysiologic measures	Rest motor threshold	baseline
Analysis of neurophysiologic measures	Active motor threshold	baseline
Analysis of neurophysiologic measures	Amplitude of motor evoked potentials	through study completion, an average of 1 year
Analysis of neurophysiologic measures	H reflex	through study completion, an average of 1 year
Analysis of neurophysiologic measures	input-output curve	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Neuromed IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Movement Disorders
• Other Study ID Numbers: NEUR_03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No