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

NCT03623386 | Completed Results

• 2 other identifiers: 20000235351K23NS099478-01A1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  4-6 weeks

• 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.

  4-6 weeks

• 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.

  Baseline and 4-6 weeks

• 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.

  Baseline and 4-6 weeks

Other Outcomes (1)

• Task-based Functional Connectivity

  1 day

Study Arms (3)

Patients with PD neurofeedback training

EXPERIMENTAL

Patients will receive neurofeedback training.

Other: PD neurofeedback

Patients with PD control

ACTIVE COMPARATOR

Patients will not receive neurofeedback training.

Other: PD control

Patients with PD

NO INTERVENTION

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

Interventions

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.

Patients with PD neurofeedback training

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.

Patients with PD control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Sule Tinaz, MD, PhD: Associate Professor of Neurology
• Organization: Yale School of Medicine

sule.tinaz@yale.edu

(877) 925-3637

Study Officials

• Sule Tinaz, MD, Phd

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 9, 2018
• Study Start: August 10, 2018
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: February 15, 2024
• Results First Posted: September 18, 2023

Record last verified: 2024-02

Locations

US (1)