Exploration of Brain Changes Due to a Targeted Ballet Program in Multiple Sclerosis

NCT ID: NCT04073940

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-29
• Study Completion Date: 2021-01-15

Brief Summary

Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system (CNS) affecting roughly 900,000 people in the United States that frequently results in impaired mobility. The majority of people with MS express that impaired mobility the most difficult aspect of living with the disease. Ataxia is one aspect of impaired mobility experienced by approximately 80% of persons with MS. Despite $9 billion in drug costs to patients with MS in the U.S., in 2012 alone, standard pharmacological treatment for MS is ineffective in restoring mobility and decreasing ataxia. The PI designed a targeted ballet program requiring motor learning of complex movements that mitigated ataxia and improved balance in patients with MS in a pilot study. The improvements obtained were approximately five times larger than those reported by other physical rehabilitation interventions. However, understanding these changes requires determining whether there are underlying changes in the brain after participation in the targeted ballet program.

This project involves persons with mild-to-moderate MS that present ataxia in their movement. We will compare the brain connectivity of participants in the targeted ballet program before and after the 16-week, twice per week, hourly participation intervention. Brain images will be obtained with magnetic resonance imaging while each participant rests with the eyes open. As a secondary outcome, measures of movement quality, ataxia, and balance will be taken to better understand the effects of the targeted ballet program on motor function, wellness, and the brains of persons with mild to moderate MS. Test on movement will include a 10 meter walk with motion tracking, a balance test using a force plate, and clinical tests of ataxia, balance, and walking speed. We will also assess changes in wellness with standard questionnaires.

Detailed Description

Multiple sclerosis (MS) is an autoimmune-mediated disease with brain demyelination and axonal loss that result in impaired mobility, which affects an estimated 75% of people with MS and is reported as the most difficult aspect of living with MS. An estimated 900,000 people in the U.S. suffer from MS, which has no known cure. In 2012 alone, drug costs to patients with MS in the U.S. were $9 billion. Despite the high costs, pharmacological interventions do not induce myelination so motor impairments persist. The PI designed a ballet-based program for complex motor learning delivered in a group setting. Our previous work provides evidence that the targeted ballet program increased balance and walking scores by 42% and decreased clinical ataxia scores by 58% over a period of 16 weeks and 32 hours of instruction. However, understanding these changes requires determining whether there are underlying changes in the brain after participation in the targeted ballet program.

The goal of this proposal is to provide evidence of improvements in brain connectivity measures after participation in the targeted ballet program in persons with MS. As secondary outcomes, we will assess motor function and wellness after participation in the targeted ballet program in persons with MS.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Targeted Ballet Program

A 16-week (32 sessions of 1 hour each) ballet-based intervention targeted to improve motor function in persons with multiple sclerosis.

Group Type: EXPERIMENTAL

Targeted Ballet Program

Intervention Type: BEHAVIORAL

All classes will be offered in a set schedule convenient for all participants. Classes will be taught by the PI, who has extensive dance training expertise. The targeted ballet program consists of an initial period of dance movements while sitting in chairs (20min), followed by exercises holding onto the ballet barres mounted to the walls in the Neuroscience of Dance on Health and Disability Laboratory (20min), followed by locomotive dance movements (20min). The dance moves are based on the Ballet I Syllabus of the Royal Academy of Dancing and the Cecchetti Council of America, designed for eight-year-old students with no necessary previous training in ballet.

Interventions

Targeted Ballet Program

All classes will be offered in a set schedule convenient for all participants. Classes will be taught by the PI, who has extensive dance training expertise. The targeted ballet program consists of an initial period of dance movements while sitting in chairs (20min), followed by exercises holding onto the ballet barres mounted to the walls in the Neuroscience of Dance on Health and Disability Laboratory (20min), followed by locomotive dance movements (20min). The dance moves are based on the Ballet I Syllabus of the Royal Academy of Dancing and the Cecchetti Council of America, designed for eight-year-old students with no necessary previous training in ballet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age between 18-64
• Informed consent obtained
• Confirmation of relapsing remitting MS (RRMS) diagnosis by the participant's neurologist
• Presence of ataxia determined by the International Cooperative Ataxia Rating Scale (ICARS) recommended by the NIH and the Ataxia Neuropharmacology Committee of the World Federation of Neurology with a score greater or equal to 7
• Expanded Disability Status Scale (EDSS) scores of 1.0-6.5 based on an examination by a Neurostatus certified examiner for indicating walking impairment
• Relapse free in the previous 30 days
• Approval for exercise training.

Exclusion Criteria

• Presence of severe cognitive impairment based on an oral Symbol Digit Modalities Test (SDMT) score of less than 23, or the Montreal Cognitive Assessment (MoCA) Test less than 22
• Inability to understand experimental instructions presented in English
• Pregnancy
• Education level less than 8th grade - due to concerns about understanding the study and consent form
• Change in use of disease modifying therapy in the previous 6 months,
• Initiation of Ampyra or other medications that influence walking and mobility within the previous 30 days,
• History of brain injury or central nervous system disease other than multiple sclerosis - this will be determined from gross anatomical abnormalities in the images or from medical history on Biomedical Imaging Center (BIC) screening form,
• Presence of orthopedic conditions,
• The presence of any skin conditions preventing the safe usage of motion tracking marker adhesives
• The presence of conditions which would contra-indicate MRI: prior surgeries and/or implant of pacemakers, pacemaker wires, artificial heart valve, brain aneurysm surgery, middle ear implant, non-removable hearing aid or jewelry, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, artificial limb or joint; foreign metallic objects in the body such as bullets, BB's, shrapnel, or metalwork fragments; pregnancy, claustrophobia, uncontrollable shaking, or inability to lie still for 2 hours.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Citlali Lopez-Ortiz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois at Urbana-Champaign

Champaign, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Citlali Lopez-Ortiz, PhD, MA

Role: CONTACT

lopezort@illinois.edu

217-300-1022

PAUL CAMACHO, BS

Role: CONTACT

pcamach2@illinois.edu

3124011603

Facility Contacts

Citlali Lopez-Ortiz, PhD, MA

Role: primary

lopezort@illinois.edu

217-300-1022

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Other Identifiers

18210

Identifier Type: -

Identifier Source: org_study_id