Non-invasive Assessment of Synaptic Plasticity

Parkinson Disease Clinical Trial

— NEUROPLAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353517
• Other study ID #: NEUR_03
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Neuromed IRCCS
• Contact: Antonio Suppa, MD, PhD
• Phone: 3494940365
• Email: antonio.suppa[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of Parkinson's disease

Exclusion Criteria:

• psychiatric disorders, including severe congnitive loss and depression

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease

Intervention

Device:
• Device: focal muscle vibration and theta burst stimulation
non invasive techniques of neuromodulation for inducing plasticity in M1 and spinal cord

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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