Exploration of Brain Changes Due to a Targeted Ballet Program in Multi
Exploration of Brain Changes Due to a Targeted Ballet Program in Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Targeted Ballet Program
What it measured
Main measures
Structural Connectivity
Before and after the 16-week intervention period
Physical functionNerve conduction testsResting-State Functional Connectivity
Before and after the 16-week intervention period
Nerve conduction tests
Other measures (7)
International Cooperative Ataxia Rating Scale (ICARS)
Before and after the 16-week intervention period
Physical functionMini Balance Evaluation Systems Test (Mini-BESTest)
Before and after the 16-week intervention period
Walking and mobility10-Meter Walk Test (10MWT)
Before and after the 16-week intervention period
Walking and mobilityWorld Health Organization Disability Assessment Schedule (WHODAS)
Before and after the 16-week intervention period
Quality of life (reported by participants)World Health Organization Five Well-Being Index (WHO-5).
Before and after the 16-week intervention period
Quality of life (reported by participants)Smoothness Index
Before and after the 16-week intervention period
Walking and mobilityStep-to-Stand Stabilization Task
Before and after the 16-week intervention period
Walking and mobility
Who could take part
Relapsing MS · 18 to 64 · EDSS 1.0 to 6.5
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Lakes KD, Sharp K, Grant-Beuttler M, Neville R, Haddad F, Sunico R, Ho D, Schneider M, Sawitz S, Paulsen J, Caputo K, Lu KD, Aminian A, Lopez-Ortiz C, Radom-Aizik S. A Six Week Therapeutic Ballet Intervention Improved Gait and Inhibitory Control in Children With Cerebral Palsy-A Pilot Study. Front Public Health. 2019 Jun 25;7:137. doi: 10.3389/fpubh.2019.00137. eCollection 2019.Background
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.Background
Scheidler 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
Larocca 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
Mills 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
Wallin 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 2Background
Hartung 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
Lakhani 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
Wittenberg 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
Solesio-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.
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History
Started
Aug 2019
Main results due
Jan 2021
Finished
Jan 2021