Non-invasive Assessment of Synaptic Plasticity
NEUROPLAST
Non-invasive Assessment of Brain and Spinal Synaptic Plasticity in Patients Affected by Movement Disorders
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 23, 2023
March 1, 2023
1 month
April 20, 2022
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Healthy Subjects
Device: focal muscle vibration to induce spinal plasticity theta burst stimulation and paired associative stimulation to induce plasticity in M1
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
Interventions
non invasive techniques of neuromodulation for inducing plasticity in M1 and spinal cord
Eligibility Criteria
25 patients with PD 25 HS
You may qualify if:
- clinical diagnosis of Parkinson's disease
You may not qualify if:
- psychiatric disorders, including severe congnitive loss and depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromed IRCCSlead
Study Sites (1)
IRCCS Neuromed
Pozzilli, 86077, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof, MD, PhD
Study Record Dates
First Submitted
April 20, 2022
First Posted
April 29, 2022
Study Start
December 1, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
March 23, 2023
Record last verified: 2023-03