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Clinical Trials/NCT05786261
NCT05786261
Recruiting
Not Applicable

Exercise and Plasticity in PD: Functional and Structural Evidence in the Cortex and the Spinal Cord

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country30 target enrollmentFebruary 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
30
Locations
1
Primary Endpoint
functional magnetic resonance
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Detailed Description

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)

Registry
clinicaltrials.gov
Start Date
February 10, 2021
End Date
February 10, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Idiophatic Parkinson Disease
  • H\&Y stage I-II stable medication

Exclusion Criteria

  • Severe comorbid medical illness (diabetes, heart disease, hypertension); history of known causative factors (encephalitis or neuroleptic treatment); other neurologic disability; chronic treatment for sleep complaints; history of seizure, including febrile seizures, family history of epilepsy; pacemakers, neurostimulators, tattoos, metal foreign bodies in the head area; recurrent visual hallucinations; fluctuating cognition, attention or alertness; depression (HAMD\> 12) or dementia (MMSE \<24).
  • Controls will be age- and education- matched subjects.

Outcomes

Primary Outcomes

functional magnetic resonance

Time Frame: 1 month

assessment of the functional and structural plasticity changes after MIRT

Secondary Outcomes

  • EMG(1 month)

Study Sites (1)

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