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Exercise and Plasticity in Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
experimental group MIRT
EEG task rTMS, fMRI
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • IRCCS Centro Neurolesi "Bonino-Pulejo"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group MIRT

control group

Arm Description

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 con task, Gait Analysis, fMRI, rTMS,

Outcomes

Primary Outcome Measures

functional magnetic resonance
assessment of the functional and structural plasticity changes after MIRT

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2023
Last Updated
March 27, 2023
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT05786261
Brief Title
Exercise and Plasticity in Parkinson Disease
Official Title
Exercise and Plasticity in PD: Functional and Structural Evidence in the Cortex and the Spinal Cord
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
February 10, 2024 (Anticipated)
Study Completion Date
February 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group MIRT
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
EEG con task, Gait Analysis, fMRI, rTMS,
Intervention Type
Device
Intervention Name(s)
experimental group MIRT
Intervention Description
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
Intervention Name(s)
EEG task rTMS, fMRI
Intervention Description
EEG task rTMS, fMRI
Primary Outcome Measure Information:
Title
functional magnetic resonance
Description
assessment of the functional and structural plasticity changes after MIRT
Time Frame
1 month
Secondary Outcome Measure Information:
Title
EMG
Description
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
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
PS EEG
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
silvia marino, MD
Phone
09060128110
Email
silvia.marino@irccsme.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
felice ghilardi, MD
Organizational Affiliation
City College of New York, New York, NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Centro Neurolesi "Bonino-Pulejo"
City
Messina
ZIP/Postal Code
98124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rossella Ciurleo
Email
rossella.ciurleo@irccsme.it

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Principal Investigator

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Exercise and Plasticity in Parkinson Disease

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