Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03623386|
Recruitment Status : Suspended (due to COVID-19 outbreak)
First Posted : August 9, 2018
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: PD neurofeedback Other: PD control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 cohort|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||double blinded|
|Official Title:||Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease: A Functional MRI Investigation|
|Actual Study Start Date :||August 10, 2018|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Patients with PD neurofeedback training
Patients will receive neurofeedback training.
Other: PD neurofeedback
PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.
Active Comparator: Patients with PD control
Patients will not receive neurofeedback training.
Other: PD control
PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
- Change in right insula-dorsomedial frontal cortex functional connectivity strength. [ Time Frame: 4-6 weeks ]The functional connectivity strength between the subjects' right insula and dorsomedial frontal cortex will be measured at baseline and post-intervention as each group of subjects engages in their respective imagery tasks. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions.
- Change in resting-state functional connectivity of the right insula and dorsomedial frontal cortex. [ Time Frame: 4-6 weeks ]We will obtain resting-state functional MRI scans from the PD-neurofeedback and PD-control groups at baseline and post-intervention to examine the changes in intrinsic functional connectivity of the right insula and dorsomedial frontal cortex with each other and with the whole brain. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions and every other brain region.
- Change in motor impairment [ Time Frame: 4-6 weeks ]We will administer the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor exam) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor impairment. The MDS-UPDRS part III is a subscale that provides an objective assessment of motor impairment. The scores range between 0-132. Higher scores indicate more severe impairment.
- Change in motor function [ Time Frame: 4-6 weeks ]We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 50-ft walk, 360-degree turn) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor function. The performance score on these tests is the time to complete the motor tasks. Shorter time indicates better performance. We will z-transform and sum the time to completion (in seconds) on each motor task to compute a composite motor function score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623386
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Sule Tinaz, MD, Phd||Yale University|