Clinical trial NCT05353517: Non-invasive Assessment of Synaptic Plasticity
Official title: Non-invasive Assessment of Brain and Spinal Synaptic Plasticity in Patients Affected by Movement Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Movement Disorders
Parkinson Disease
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 25 patients with PD 25 HS

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.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* psychiatric disorders, including severe congnitive loss and depression

Primary outcomes:
measure: Analysis of neurophysiologic measures
timeFrame: baseline
measure: Analysis of neurophysiologic measures
timeFrame: baseline
measure: Analysis of neurophysiologic measures
timeFrame: through study completion, an average of 1 year
measure: Analysis of neurophysiologic measures
timeFrame: through study completion, an average of 1 year
measure: Analysis of neurophysiologic measures
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
References: