Multiple Sclerosis, Relapsing-RemittingNCT04073940
Exploration of Brain Changes Due to a Targeted Ballet Program in Multiple Sclerosis
A study testing Targeted Ballet Program in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Targeted Ballet Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Champaign, Illinois, 61820
Citlali Lopez-Ortiz, PhD, MA, 217-300-1022, lopezort@illinois.edu
About this study
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.
Read the 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
- Being tested
- Targeted Ballet Program
- Keywords
- multiple sclerosis, ataxia, magnetic resonance imaging, structural connectivity, resting state functional connectivity, dance, wellness, balance, mobility
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Ballet ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Ballet Program | Experimental | A 16-week (32 sessions of 1 hour each) ballet-based intervention targeted to improve motor function in persons with multiple sclerosis. Receives: Behavioral: Targeted Ballet Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before and after the 16-week intervention period
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.
Measured: Before and after the 16-week intervention period
Secondary outcomes (7)
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.
Measured: Before and after the 16-week intervention period
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.
Measured: Before and after the 16-week intervention period
10-Meter Walk Test (10MWT)
A clinical test of walking ability by time to complete a 10-meter long walk.
Measured: Before and after the 16-week intervention period
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.
Measured: Before and after the 16-week intervention period
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.
Measured: Before and after the 16-week intervention period
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).
Measured: Before and after the 16-week intervention period
Step-to-Stand Stabilization Task
Participant will step onto and stand still on a force plate to quantitatively measure static and dynamic balance.
Measured: Before and after the 16-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start29 Aug 2019
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (100)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073940
- Sponsor's protocol ID
- 18210
- Status last verified
- Dec 2019
- First submitted
- 27 Aug 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Bollaert RE, Poe K, Hubbard EA, Motl RW, Pilutti LA, Johnson CL, Sutton BP. Associations of functional connectivity and walking performance in multiple sclerosis. Neuropsychologia. 2018 Aug;117:8-12. doi: 10.1016/j.neuropsychologia.2018.05.007. Epub 2018 May 8.
PubMed 29750986Scheidler AM, Kinnett-Hopkins D, Learmonth YC, Motl R, Lopez-Ortiz C. Targeted ballet program mitigates ataxia and improves balance in females with mild-to-moderate multiple sclerosis. PLoS One. 2018 Oct 18;13(10):e0205382. doi: 10.1371/journal.pone.0205382. eCollection 2018.
PubMed 30335774Larocca NG. Impact of walking impairment in multiple sclerosis: perspectives of patients and care partners. Patient. 2011;4(3):189-201. doi: 10.2165/11591150-000000000-00000.
PubMed 21766914Mills RJ, Yap L, Young CA. Treatment for ataxia in multiple sclerosis. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005029. doi: 10.1002/14651858.CD005029.pub2.
PubMed 17253537Wallin MT, Culpepper WJ, Campbell JD, Nelson LM, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Tremlett H, Buka SL, Dilokthornsakul P, Topol B, Chen LH, LaRocca NG; US Multiple Sclerosis Prevalence Workgroup. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019 Mar 5;92(10):e1029-e1040. doi: 10.1212/WNL.0000000000007035. Epub 2019 Feb 15.
PubMed 30770430Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24.
PubMed 25911108Lakhani B, Borich MR, Jackson JN, Wadden KP, Peters S, Villamayor A, MacKay AL, Vavasour IM, Rauscher A, Boyd LA. Motor Skill Acquisition Promotes Human Brain Myelin Plasticity. Neural Plast. 2016;2016:7526135. doi: 10.1155/2016/7526135. Epub 2016 May 16.
PubMed 27293906Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016.
PubMed 28357039Solesio-Jofre E, Beets IAM, Woolley DG, Pauwels L, Chalavi S, Mantini D, Swinnen SP. Age-Dependent Modulations of Resting State Connectivity Following Motor Practice. Front Aging Neurosci. 2018 Feb 6;10:25. doi: 10.3389/fnagi.2018.00025. eCollection 2018.
PubMed 29467646Scholz J, Klein MC, Behrens TE, Johansen-Berg H. Training induces changes in white-matter architecture. Nat Neurosci. 2009 Nov;12(11):1370-1. doi: 10.1038/nn.2412. Epub 2009 Oct 11.
PubMed 19820707Taubert M, Draganski B, Anwander A, Muller K, Horstmann A, Villringer A, Ragert P. Dynamic properties of human brain structure: learning-related changes in cortical areas and associated fiber connections. J Neurosci. 2010 Sep 1;30(35):11670-7. doi: 10.1523/JNEUROSCI.2567-10.2010.
PubMed 20810887Moore E, Schaefer RS, Bastin ME, Roberts N, Overy K. Diffusion tensor MRI tractography reveals increased fractional anisotropy (FA) in arcuate fasciculus following music-cued motor training. Brain Cogn. 2017 Aug;116:40-46. doi: 10.1016/j.bandc.2017.05.001. Epub 2017 Jun 12.
PubMed 28618361Burzynska AZ, Jiao Y, Knecht AM, Fanning J, Awick EA, Chen T, Gothe N, Voss MW, McAuley E, Kramer AF. White Matter Integrity Declined Over 6-Months, but Dance Intervention Improved Integrity of the Fornix of Older Adults. Front Aging Neurosci. 2017 Mar 16;9:59. doi: 10.3389/fnagi.2017.00059. eCollection 2017.
PubMed 28360853Clayden JD. Imaging connectivity: MRI and the structural networks of the brain. Funct Neurol. 2013 Jul-Sep;28(3):197-203.
PubMed 24139656Beaulieu C. The basis of anisotropic water diffusion in the nervous system - a technical review. NMR Biomed. 2002 Nov-Dec;15(7-8):435-55. doi: 10.1002/nbm.782.
PubMed 12489094
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Brain Changes Due to a Targeted Ballet Program in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04073940
- Acronym / sponsor ID
- 18210
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- multiple sclerosis, ataxia, magnetic resonance imaging, structural connectivity, resting state functional connectivity, dance, wellness, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Ballet Program | Experimental | Behavioral: Targeted Ballet ProgramA 16-week (32 sessions of 1 hour each) ballet-based intervention targeted to improve motor function in persons with multiple sclerosis. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Ballet ProgramAll 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. | Behavioural | Targeted Ballet Program |
Primary outcome
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).
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.
7 secondary outcomes
International Cooperative Ataxia Rating Scale (ICARS)
Time frame: Before and after the 16-week intervention period
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Before and after the 16-week intervention period
10-Meter Walk Test (10MWT)
Time frame: Before and after the 16-week intervention period
World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: Before and after the 16-week intervention period
World Health Organization Five Well-Being Index (WHO-5).
Time frame: Before and after the 16-week intervention period
Smoothness Index
Time frame: Before and after the 16-week intervention period
Step-to-Stand Stabilization Task
Time frame: Before and after the 16-week intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Background: PubMed 29750986Bollaert RE, Poe K, Hubbard EA, Motl RW, Pilutti LA, Johnson CL, Sutton BP. Associations of functional connectivity and walking performance in multiple sclerosis. Neuropsychologia. 2018 Aug;117:8-12. doi: 10.1016/j.neuropsychologia.2018.05.007. Epub 2018 May 8.
- Background: PubMed 30335774Scheidler AM, Kinnett-Hopkins D, Learmonth YC, Motl R, Lopez-Ortiz C. Targeted ballet program mitigates ataxia and improves balance in females with mild-to-moderate multiple sclerosis. PLoS One. 2018 Oct 18;13(10):e0205382. doi: 10.1371/journal.pone.0205382. eCollection 2018.
- Background: PubMed 21766914Larocca NG. Impact of walking impairment in multiple sclerosis: perspectives of patients and care partners. Patient. 2011;4(3):189-201. doi: 10.2165/11591150-000000000-00000.
- Background: PubMed 17253537Mills RJ, Yap L, Young CA. Treatment for ataxia in multiple sclerosis. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005029. doi: 10.1002/14651858.CD005029.pub2.
- Background: PubMed 30770430Wallin MT, Culpepper WJ, Campbell JD, Nelson LM, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Tremlett H, Buka SL, Dilokthornsakul P, Topol B, Chen LH, LaRocca NG; US Multiple Sclerosis Prevalence Workgroup. The prevalence of MS in the United States: A population-based estimate using health claims data. Neurology. 2019 Mar 5;92(10):e1029-e1040. doi: 10.1212/WNL.0000000000007035. Epub 2019 Feb 15.
- Background: PubMed 25911108Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24.
- Background: PubMed 27293906Lakhani B, Borich MR, Jackson JN, Wadden KP, Peters S, Villamayor A, MacKay AL, Vavasour IM, Rauscher A, Boyd LA. Motor Skill Acquisition Promotes Human Brain Myelin Plasticity. Neural Plast. 2016;2016:7526135. doi: 10.1155/2016/7526135. Epub 2016 May 16.
- Background: PubMed 28357039Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016.
- Background: PubMed 29467646Solesio-Jofre E, Beets IAM, Woolley DG, Pauwels L, Chalavi S, Mantini D, Swinnen SP. Age-Dependent Modulations of Resting State Connectivity Following Motor Practice. Front Aging Neurosci. 2018 Feb 6;10:25. doi: 10.3389/fnagi.2018.00025. eCollection 2018.
- Background: PubMed 19820707Scholz J, Klein MC, Behrens TE, Johansen-Berg H. Training induces changes in white-matter architecture. Nat Neurosci. 2009 Nov;12(11):1370-1. doi: 10.1038/nn.2412. Epub 2009 Oct 11.
- Background: PubMed 20810887Taubert M, Draganski B, Anwander A, Muller K, Horstmann A, Villringer A, Ragert P. Dynamic properties of human brain structure: learning-related changes in cortical areas and associated fiber connections. J Neurosci. 2010 Sep 1;30(35):11670-7. doi: 10.1523/JNEUROSCI.2567-10.2010.
- Background: PubMed 28618361Moore E, Schaefer RS, Bastin ME, Roberts N, Overy K. Diffusion tensor MRI tractography reveals increased fractional anisotropy (FA) in arcuate fasciculus following music-cued motor training. Brain Cogn. 2017 Aug;116:40-46. doi: 10.1016/j.bandc.2017.05.001. Epub 2017 Jun 12.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Multiple Sclerosis, Relapsing-Remitting
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Ballet Program in people with Multiple Sclerosis, Relapsing-Remitting, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Citlali Lopez-Ortiz, PhD, MA (217-300-1022, lopezort@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Connectivity (time frame: Before and after the 16-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073940, which also lists 100 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.