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Exercise and Plasticity in Parkinson Disease

NCT05786261 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-29

No results posted yet for this study

Summary

We will study the effects of intensive rehabilitation in PD on plasticity with a multimodal approach. We will define first, whether exercise in PD restores the potentiation of the motor cortex to normal levels with both 5 Hz-rTMS PAS and beta modulation and whether such improvements are accompanied by structural changes studied with diffusion MRI tractography and network analysis (Aim 1). With the study of muscle synergies and spatiotemporal organization of the spinal motoneuronal output during gait and reaching movements we will define the presence of functional changes in spinal cord mechanisms and connectivity and whether such changes are global or involve selective districts (Aim 2). Finally, we will study post-exercise changes in sleep pattern, as sleep is impaired in PD and plays a crucial role in the definition of plasticity-related phenomena (Aim 3). This project will generate breakthrough data on the mechanisms of exercise, novel biomarkers to monitor efficacy of treatments and thus, possibly leading to better restorative, disease-modifying and symptomatic therapies for PD.

Conditions

  • Parkinson Disease

Interventions

DEVICE

experimental group MIRT

Task 1a: Assessing the effect of MIRT on cortical plasticity tested with rPAS Task 1b: Assessing the effect of MIRT on structural cortical plasticity and brain connectivity tested with MRI Task 1c: Assessing the effect of MIRT on movement-related beta modulation Task 1d: Assessing the effects of MIRT on motor skills formation with reaching tasks Task 1e: Assessing the effects of MIRT on EEG correlates of motor skills formation Task 2a: Assessing the effect of MIRT on muscle synergies during gait Task 2b: Assessing the effect of MIRT on muscle synergies during reaching movements Task 3a: Assessing the effect of MIRT on sleep microstructure

DEVICE

EEG task rTMS, fMRI

EEG task rTMS, fMRI

Sponsors & Collaborators

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Principal Investigators

  • felice ghilardi, MD · City College of New York, New York, NY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2024-02-10
Completion
2024-02-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786261 on ClinicalTrials.gov