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

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ClinicalTrials.gov Identifier: NCT04073940
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Behavioral: Targeted Ballet Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploration of Brain Changes Due to a Targeted Ballet Program in Multiple Sclerosis
Estimated Study Start Date : August 20, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Structural Connectivity [ Time Frame: Before and after the 16-week intervention period ]
    Mean strength, global efficiency, and mean clustering coefficient for the networks seeded from the regions of interest: the fornix, supplemental motor area, corpus callosum, orbitofrontal cortex, putamen, and cerebellum. Using Probtrackx2 in network mode, the output is a connectivity martix, which contains the number of streamlines from each seed volume (e.g., all voxels in insula cortex) that reached all other target regions. Structural connections will be normalized by the average volume of each region of interest (ROI) comprising the particular pathway to eliminate bias induced from larger ROI's. Additionally, the structural connectomes will be symmetrized by averaging the two connections in the connectivity matrix corresponding to the pair of ROI's (where one connection is ROI 1 as seed and ROI 2 as target, and the other connection flips the seed and target labels).

  2. Resting-State Functional Connectivity [ Time Frame: Before and after the 16-week intervention period ]
    We will acquire one 8 minute scan for resting state functional connectivity analysis, during which participants will be instructed to maintain their eyes open and focus on a fixation point as was done in Bollaert et al. 2018. We will use a modified version of the Duke Brain Imaging and Analysis Center's (BIAC) resting-state functional connectivity to find the correlation coefficients of the resting-state blood oxygen level-dependent activation of the 68 regions from Freesurfer's parcellation and the 34 regions of the cerebellum from the spatially unbiased atlas template of the cerebellum and brainstem (SUIT) parcellation. We will use the brain connectivity toolbox (BCT) to form graph-theoretical measures of the network for evaluating changes in connectivity.


Secondary Outcome Measures :
  1. International Cooperative Ataxia Rating Scale (ICARS) [ Time Frame: Before and after the 16-week intervention period ]
    The ICARS is the leading comprehensive clinical measure of ataxia for persons with MS, which has strong inter-evaluator reliability and validity.

  2. Mini Balance Evaluation Systems Test (Mini-BESTest) [ Time Frame: Before and after the 16-week intervention period ]
    This test consists of a shorter list of evaluations on six factors that may impair balance in patients with MS: biomechanics, stability limits, postural responses, anticipatory postural adjustments, sensory orientation, and dynamic balance during gait.

  3. 10-Meter Walk Test (10MWT) [ Time Frame: Before and after the 16-week intervention period ]
    A clinical test of walking ability by time to complete a 10-meter long walk.

  4. World Health Organization Disability Assessment Schedule (WHODAS) [ Time Frame: Before and after the 16-week intervention period ]
    Questionnaire-based assessment of wellness and quality of life as related to disability.

  5. World Health Organization Five Well-Being Index (WHO-5). [ Time Frame: Before and after the 16-week intervention period ]
    Questionnaire-based assessment of wellness and quality of life.

  6. Smoothness Index [ Time Frame: Before and after the 16-week intervention period ]
    Quantitative measure of smoothness of movement will be obtained for walking by computing a standard smoothness index on velocity data of body landmarks such as wrists, elbows, shoulders, hips, knees, toes, ankles, and top of head in a 5 meter walk using a motion capture system (Qualisys, Sweden).

  7. Step-to-Stand Stabilization Task [ Time Frame: Before and after the 16-week intervention period ]
    Participant will step onto and stand still on a force plate to quantitatively measure static and dynamic balance.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Age between 18-64, (2) informed consent obtained, (3) confirmation of relapsing remitting MS (RRMS) diagnosis by the participant's neurologist, (4) 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, (5) Expanded Disability Status Scale (EDSS) scores of 1.0-6.5 based on an examination by a Neurostatus certified examiner for indicating walking impairment, (6) relapse free in the previous 30 days, and (7) approval for exercise training.

Exclusion Criteria:

  • (1) 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, (2) inability to understand experimental instructions presented in English, (3) pregnancy, (4) education level less than 8th grade - due to concerns about understanding the study and consent form, (5) change in use of disease modifying therapy in the previous 6 months, (6) initiation of Ampyra or other medications that influence walking and mobility within the previous 30 days, (7) 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, (8) presence of orthopedic conditions, (9) the presence of any skin conditions preventing the safe usage of motion tracking marker adhesives (10) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073940


Contacts
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Contact: Citlali Lopez-Ortiz, PhD, MA 217-300-1022 lopezort@illinois.edu
Contact: PAUL CAMACHO, BS 3124011603 pcamach2@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana-Champaign Recruiting
Champaign, Illinois, United States, 61820
Contact: Citlali Lopez-Ortiz, PhD, MA    217-300-1022    lopezort@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign

Publications of Results:
Other Publications:

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Responsible Party: Citlali Lopez-Ortiz, Assistant Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04073940     History of Changes
Other Study ID Numbers: 18210
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data will be kept for 5 years after publication, as required by the American Psychological Association. De-identified data will be stored in the Neuroscience Information Framework database for further use.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign:
multiple sclerosis
ataxia
magnetic resonance imaging
structural connectivity
resting state functional connectivity
dance
wellness
balance
mobility
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases