Skip to main content
OpenTrials
Completed

NCT Number: NCT03623386

Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease

Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals with Parkinson's Disease: A functional MRI investigation.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

About this study

This project will examine the effect of functional MRI-based neurofeedback on brain plasticity and motor performance in patients with Parkinson's Disease (PD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a diagnosis of idiopathic PD defined according to the UK Brain Bank diagnostic criteria and on a stable dopaminergic medication regimen will be included.

Exclusion criteria

  • Age < 40 years
  • Non-English speaking
  • Pregnancy
  • Breastfeeding
  • Excessive alcohol consumption (> 7 drinks per week for women, > 14 drinks per week for men) or substance use
  • History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
  • History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive compulsive disorder
  • History of head injury with loss of consciousness
  • Metallic surgical implants or traumatically implanted metallic foreign bodies
  • Inability to lie flat for about an hour
  • Discomfort being in small, enclosed spaces
  • Dementia (Montreal Cognitive Assessment score < 21)
  • Depression (Beck Depression Inventory-II score > 19)
  • Hoehn & Yahr stage > 3 (i.e., able to stand and walk, but not fully independent)
  • Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism
  • Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-UPDRS resting tremor score > 1 in limbs, head/chin tremor, or dyskinesia by history or exam).

Treatment and study plan

PD neurofeedback

Other

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.

PD control

Other

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.

Primary outcomes

  1. 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.

  2. Change in Resting-state Functional Connectivity Between 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 between the right insula and dorsomedial frontal cortex. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions.

  3. Change in Motor Impairment

    Time frame: Baseline and 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.

  4. Change in Motor Function

    Time frame: Baseline and 4-6 weeks

    We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 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. The motor function tests measure movement speed. Timed up and go test measures (seconds) how fast one can stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down again. Five times sit-to-stand test measures (seconds) how fast one can stand up from a chair with arms crossed across the chest and sit back again 5 times in a row. 360-degree turn test measures (seconds) how fast one can turn around their own axis clockwise and counterclockwise. The composite motor function score is the sum of the durations (seconds) of all three tests.

Other outcomes

  1. Task-based Functional Connectivity

    Time frame: 1 day

    In a group of PD patients who will not receive any intervention, we will collect functional MRI data during a mental imagery task with both motor and visual imagery components to investigate the functional connectivity between the motor and visual networks.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease: A Functional MRI Investigation

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2018
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.