Non-invasive Assessment of Synaptic Plasticity

NCT ID: NCT05353517

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-12-31

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.

Conditions

Movement Disorders; Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Subjects

Device: focal muscle vibration to induce spinal plasticity theta burst stimulation and paired associative stimulation to induce plasticity in M1

Device: focal muscle vibration and theta burst stimulation

Intervention Type: DEVICE

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: focal muscle vibration and theta burst stimulation

Intervention Type: DEVICE

non invasive techniques of neuromodulation for inducing plasticity in M1 and spinal cord

Interventions

Device: focal muscle vibration and theta burst stimulation

non invasive techniques of neuromodulation for inducing plasticity in M1 and spinal cord

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of Parkinson's disease

Exclusion Criteria

• psychiatric disorders, including severe congnitive loss and depression

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Antonio Suppa

Prof, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Neuromed

Pozzilli, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Suppa, MD, PhD

Role: CONTACT

antonio.suppa@uniroma1.it

3494940365 ext. +0039

Francesco Asci, MD

Role: CONTACT

francesco.asci@uniroma1.it

3488263444 ext. +0039

Facility Contacts

Antonio Suppa, MD

Role: primary

+00390649914074

Other Identifiers

NEUR_03

Identifier Type: -

Identifier Source: org_study_id