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WithdrawnNCT03404388Updated Aug 19, 2026

Brain and Behavioral Influences on Motor Skill Learning in Multiple Sclerosis

An interventional study of Balance Training in Multiple Sclerosis, sponsored by Wayne State University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Wayne State University · Not applicable, Interventional, and Screening

Why this study was withdrawn
This study did not receive funding and was therefore withdrawn prior to enrollment of participants.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of Relapsing-Remitting MS,
  2. Patient Determined Disease Steps (PDDS) \<6.5, indicating ability to ambulate with or without an assistive device (Hohol, 1999; Learmonth, 2013)
  3. between the ages of 18 and 65;
  4. stable medication regime for 3 months prior to enrollment, and
  5. able to follow study-related commands.

Exclusion criteria

Exclusion Criteria:

  1. history of other neurological or neuromuscular conditions,
  2. acute orthopedic conditions that prevent participation in the training,
  3. steroid use \<30 days prior to enrollment;
  4. history of alcohol abuse;
  5. presence of metallic implants, medical implants or exposure to metallic shrapnel incompatible with MRI,
  6. pregnancy;
  7. history of hospitalization for depression; and
  8. depression as evidenced by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke, 2001), as depression has been shown to impact motor learning in persons with neurologic disorders (Subramanian, 2015).
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental

    Balance Training

    Behavioral: Balance Training

Interventions

  • BehavioralBalance Training

    4 days of a challenging balance training task

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What researchers measure

Primary outcomes

  1. Change in Dual-Task Cost

    Performance of challenging balance task at the same time as a cognitive task

    Time frame: Outcome will be assessed at baseline visit and post-test visit (1 week later)

Secondary outcomes

  1. Berg Balance Scale

    Clinical test of balance

    Time frame: Outcome will be assessed at baseline visit and post-test visit (1 week later)

  2. Objective Balance Control

    Assessment of static and dynamic balance as well as anticipatory postural control with wearable sensors

    Time frame: Outcome will be assessed at baseline visit and post-test visit (1 week later)

06

Study locations

1 site
  • Wayne State University
    Detroit, Michigan 48201, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03404388
Lead sponsor
Wayne State University
Responsible party
Nora Fritz (Assistant Professor, Wayne State University) — Principal investigator
First posted
Jan 19, 2018
Start date
Apr 1, 2020
Primary completion
Aug 17, 2026
Completion
Aug 17, 2026
Last update
Aug 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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