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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: PD control; Other: PD neurofeedback

• Registration Number: NCT03623386
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-08-10
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Results First Submitted: 2023-07-12
• Results First Submitted QC: 2023-09-15
• Results First Posted: 2023-09-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with PD control	PD control	Patients will not receive neurofeedback training.
Patients with PD neurofeedback training	PD neurofeedback	Patients will receive neurofeedback training.

Primary Outcome Measures

Name	Time	Method
Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex.	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.
Change in Motor Impairment	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.
Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength.	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 Motor Function	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.

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States