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

Status unconfirmed · Not applicable

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID

NCT04073940

Run by

University of Illinois at Urbana-Champaign

People needed

30

Starts

2019-08-29

Expected to finish

2021-01-15

Last updated by the study team

2020-01-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Illinois at Urbana-Champaign — Champaign, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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