Clinical trial NCT03623386: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2018-08-09
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength.
timeFrame: 4-6 weeks
measure: Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex.
timeFrame: 4-6 weeks
measure: Change in Motor Impairment
timeFrame: Baseline and 4-6 weeks
measure: Change in Motor Function
timeFrame: Baseline and 4-6 weeks
Secondary outcomes:
Other outcomes:
measure: Task-based Functional Connectivity
timeFrame: 1 day
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Sule Tinaz, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: