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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PD neurofeedback
PD control
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Patients with PD neurofeedback training

Patients with PD control

Patients with PD

Arm Description

Patients will receive neurofeedback training.

Patients will not receive neurofeedback training.

Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training.

Outcomes

Primary Outcome Measures

Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength.
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 Between the Right Insula and Dorsomedial Frontal Cortex.
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2018
Last Updated
September 15, 2023
Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03623386
Brief Title
Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease
Official Title
Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease: A Functional MRI Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

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
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).

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
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with PD neurofeedback training
Arm Type
Experimental
Arm Description
Patients will receive neurofeedback training.
Arm Title
Patients with PD control
Arm Type
Active Comparator
Arm Description
Patients will not receive neurofeedback training.
Arm Title
Patients with PD
Arm Type
No Intervention
Arm Description
Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training.
Intervention Type
Other
Intervention Name(s)
PD neurofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PD control
Intervention Description
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 Outcome Measure Information:
Title
Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength.
Description
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.
Time Frame
4-6 weeks
Title
Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex.
Description
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.
Time Frame
4-6 weeks
Title
Change in Motor Impairment
Description
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.
Time Frame
Baseline and 4-6 weeks
Title
Change in Motor Function
Description
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.
Time Frame
Baseline and 4-6 weeks
Other Pre-specified Outcome Measures:
Title
Task-based Functional Connectivity
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sule Tinaz, MD, Phd
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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

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