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

NCT ID: NCT03623386

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2022-09-16

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).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients with PD neurofeedback training

Patients will receive neurofeedback training.

Group Type: EXPERIMENTAL

PD neurofeedback

Intervention Type: 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 control

Patients will not receive neurofeedback training.

Group Type: ACTIVE_COMPARATOR

PD control

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sule Tinaz, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23NS099478-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023535

Identifier Type: -

Identifier Source: org_study_id