Exercise and Plasticity in Parkinson Disease

NCT ID: NCT05786261

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2024-02-10

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)

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

experimental group MIRT

Intervention Type: DEVICE

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

EEG task rTMS, fMRI

Intervention Type: DEVICE

EEG task rTMS, fMRI

control group

EEG con task, Gait Analysis, fMRI, rTMS,

Group Type: ACTIVE_COMPARATOR

EEG task rTMS, fMRI

Intervention Type: DEVICE

EEG task rTMS, fMRI

Interventions

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

Intervention Type: DEVICE

EEG task rTMS, fMRI

EEG task rTMS, fMRI

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

felice ghilardi, MD

Role: PRINCIPAL_INVESTIGATOR

City College of New York, New York, NY

Locations

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

silvia marino, MD

Role: CONTACT

silvia.marino@irccsme.it

09060128110

Facility Contacts

Rossella Ciurleo

Role: primary

rossella.ciurleo@irccsme.it

Other Identifiers

PD180091

Identifier Type: -

Identifier Source: org_study_id