150 Participants Needed

Balance Training for Multiple Sclerosis

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wayne State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Multiple Sclerosis (MS) is characterized by episodic attacks in which there are sharp declines in physical function. Although neurorehabilitation is the most promising clinical strategy for motor recovery in patients with MS, treatment responsiveness and outcomes are mixed. This is perhaps because each individual with MS has a different capacity to improve with rehabilitation, and this capacity may be based on a variety of baseline factors, such as disease duration, motivation, cognitive status and integrity of underlying brain structures. A better understanding of what "key ingredients" facilitate relearning of motor skills during neurorehabilitation is critically needed. Much of the focus of rehabilitation is on relearning motor skills. The initial stage of learning a motor skills often requires explicit concentration on the details of the movement. As one becomes more proficient in the motor skill, it becomes less attention-demanding and more automatic. Those who can perform motor skills more automatically will be better able to manage the additional demands of a secondary task; thus, capacity for dual-task performance can be used as an index of automaticity. Individuals with MS experience demyelination that impacts brain areas critical for motor learning. However, the specific clinical and pathological variables that facilitate capacity for motor learning in people with MS have not been identified. Identification of such variables could be leveraged to determine a patient's capacity to benefit from neurorehabilitation at the outset and potentially to maximize motor learning during rehabilitation for people with MS. Thus, there is an urgent need to determine the key ingredients most strongly associated with successful relearning of motor skills in MS patients.Our long-term goal is to develop individualized rehabilitation for persons with MS. Our overall objective in this application is to identify clinical and pathological variables associated with successful relearning of motor skills. Our central hypothesis, based on preliminary data, is that the ability to learn to make new movements automatically occurs over a dynamic range and is a function of available cognitive processing speed and the integrity of corticospinal tract and superior cerebellar peduncles. We will test these hypotheses by recruiting 146 individuals with relapsing-remitting MS to participate in a mechanistic trial not designed to be a therapeutic intervention. Participants will complete baseline testing (including neuroimaging, cognitive testing and dual-task performance) followed by 4 consecutive days of training on a challenging balance task. After a 2-day washout period, participants will return for post-testing (including dual-task performance on a dual-balance and working memory task). The rationale for the proposed research is that identification of key ingredients associated with the capacity for motor skill acquisition would allow for more targeted rehabilitation programming, thereby improving patient outcomes and reducing health care expenses.At the completion of the proposed research, we expect to understand more about the capacity for individuals with MS to improve with motor skill training, and some of the key ingredients that help predict successful shift toward task automaticity, one critical component of successful neurorehabilitation. The results of this proposal will facilitate the development of predictors of motor recovery, needed to improve rehabilitation outcomes for individuals with MS and other neurodegenerative diseases.

Eligibility Criteria

This trial is for individuals aged 18-65 with Relapsing-Remitting Multiple Sclerosis who can walk with or without help. They must have been on a stable medication regime for the past 3 months and be able to follow study instructions. People are excluded if they have other neurological conditions, recent steroid use, metal implants incompatible with MRI, current pregnancy, or significant depression.

Inclusion Criteria

My medications have not changed in the last 3 months.
I can understand and follow study instructions.
I can walk with or without help.
See 1 more

Exclusion Criteria

I haven't taken steroids in the last 30 days.
History of alcohol abuse
Presence of metallic implants, medical implants or exposure to metallic shrapnel incompatible with MRI
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants complete baseline testing including neuroimaging, cognitive testing, and dual-task performance

1 week
1 visit (in-person)

Training

Participants undergo 4 consecutive days of training on a challenging balance task

1 week
4 visits (in-person)

Washout Period

A 2-day washout period before post-testing

2 days

Post-Testing

Participants return for post-testing including dual-task performance on a dual-balance and working memory task

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

Treatment Details

Interventions

  • Balance Training
Trial Overview The study investigates how people with MS relearn motor skills through balance training. It aims to identify clinical and brain-related factors that predict successful learning of these skills. Participants will undergo cognitive tests, neuroimaging, and train on a balance task over four days followed by post-testing after two days.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Balance Training

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Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials
318
Recruited
111,000+
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