Multiple Sclerosis, Relapsing-Remitting Clinical Trial
Official title:
Exploration of Brain Changes Due to a Targeted Ballet Program in Multiple Sclerosis
NCT number | NCT04073940 |
Other study ID # | 18210 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 29, 2019 |
Est. completion date | January 15, 2021 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Urbana-Champaign | Champaign | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Structural Connectivity | 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). | Before and after the 16-week intervention period | |
Primary | Resting-State Functional Connectivity | 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. | Before and after the 16-week intervention period | |
Secondary | International Cooperative Ataxia Rating Scale (ICARS) | The ICARS is the leading comprehensive clinical measure of ataxia for persons with MS, which has strong inter-evaluator reliability and validity. | Before and after the 16-week intervention period | |
Secondary | Mini Balance Evaluation Systems Test (Mini-BESTest) | 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. | Before and after the 16-week intervention period | |
Secondary | 10-Meter Walk Test (10MWT) | A clinical test of walking ability by time to complete a 10-meter long walk. | Before and after the 16-week intervention period | |
Secondary | World Health Organization Disability Assessment Schedule (WHODAS) | Questionnaire-based assessment of wellness and quality of life as related to disability. 36 items are used to assess disability-related wellness. Difficulty in the past 30 days for each item is scored between 1 (none) and 5 (extreme or cannot do). Six domains are assessed: Understanding and communicating (6 to 30), Getting around (5 to 25), Self-care (4 to 20), Getting along with people (5 to 25), Life activities (8 to 40), and Participation in society (8 to 40) The minimum sum score of 36 indicates no disability-related wellness problems and the maximum score of 180 indicates extreme disability-related wellness problems. | Before and after the 16-week intervention period | |
Secondary | World Health Organization Five Well-Being Index (WHO-5). | Questionnaire-based assessment of wellness and quality of life over the last two weeks. A minimum sum score of 0 (0 on each of five questions) indicates minimal well-being. A maximum score of 25 (5 on each of five questions) indicates maximum well-being. | Before and after the 16-week intervention period | |
Secondary | Smoothness Index | 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). | Before and after the 16-week intervention period | |
Secondary | Step-to-Stand Stabilization Task | Participant will step onto and stand still on a force plate to quantitatively measure static and dynamic balance. | Before and after the 16-week intervention period |
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