Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623386
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals with Parkinson's Disease: A functional MRI investigation.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: PD neurofeedback Other: PD control Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 cohort
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blinded
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sule Tinaz, MD, PhD 203-737-6158 sule.tinaz@yale.edu

Locations
Layout table for location information
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Sule Tinaz, MD, PhD    203-737-6158    sule.tinaz@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Sule Tinaz, MD, Phd Yale University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03623386    
Other Study ID Numbers: 2000023535
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases