Exercise and Plasticity in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786261
• Other study ID #: PD180091
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2023
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: silvia marino, MD
• Phone: 09060128110
• Email: silvia.marino[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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
• EEG task rTMS, fMRI
EEG task rTMS, fMRI

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi "Bonino-Pulejo"	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PS EEG	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	1 month
Primary	functional magnetic resonance	assessment of the functional and structural plasticity changes after MIRT	1 month
Secondary	EMG	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	1 month