RightFit
RecruitingEarly Phase 1

Gait Adaptation Study

Integrative Training Approach for Inducing Neuroplasticity in Multiple Sclerosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 3 visits, 12 visits
  • Time periods mentioned: 4 weeks, 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "GAT will involve completing 12 training sessions using mixed reality (MR) over 4 weeks."
  • "Upon satisfying inclusion/exclusion criteria, participants in this aim will attend a one visit session and complete the baseline measurements in aims 1\&2 detailed above (mobility, cognitive, and neuroimaging outcome assessments)."
  • "Aim 1a consists of one visit for \~2 hours."
  • "Aim 1b \& 2 consist of: three assessment visits \~3 hours each; and 12 training visits 1 hour each."
  • "A total of 21 hours over 12 weeks to complete study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests training to help people with multiple sclerosis (MS) with movement, sensing, and thinking skills. It aims to improve how the brain and muscles work together. The listed entry rules are for adults ages 18 to 80 with MS, though the study also describes studying children with MS and two related conditions, MOG and NMOSD.

This pilot study proposes a clinical trial to target treatment of sensorimotor and cognitive deficits in persons with Multiple Sclerosis (pwMS). The proposal has the potential to promote neuroplasticity and induce re-normalization in brain to muscle (cortico-muscular) connectivity (BMC) and within brain connectivity via an integrative training approach. Preliminary data and published work are available to inform specific aspects of the proposed trial, along with the general rationale for exploring the suggested rehabilitation approach. However, there is a gap in research on the effects of training that uses the proposed approach via a clinical trial (of any phase) in pwMS to support the rationale for exploring the suggested rehabilitation training approach. Moreover, there is no pilot data on the training itself in the same population. This study will examine the behavioral deficits and neural characteristics in children with MS and two other related conditions (Myelin Oligodendrocyte Glycoprotein (MOG) and Nueromyelitis Optica Spectrum Disorder (NMOSD)) to understand if they would benefit from rehabilitation training conditions tested in aims 1 and 2. The overall long term goal is to improve rehabilitation training conditions for both adults and children with MS.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 80 years old.
  • Have a confirmed diagnosis of MS.
  • Be able to pay attention to a computer screen and follow instructions in English.
  • Score more than 24 out of 30 on the MiniMental test, which checks thinking skills.
  • Be right-handed, based on a handedness test.
  • Report normal vision, with or without glasses or contacts.

Who can't join

  • Have a mental health condition that needs treatment, because medicines may affect brain activity.
  • Have another nervous system condition, such as a brain injury or stroke, that may affect thinking, balance, or physical health.
  • Have a bone or joint injury, or a nerve and muscle disorder, that may affect balance or movement.
  • Take part in another thinking-skills or physical training program while in this study.
  • Have an ongoing relapse, meaning new or returning nervous system symptoms, or have had steroid treatment in the 30 days before joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 to 80 yrs Clinically definite MS diagnosis Ability to attend to computer screen and follow instructions in English which will be assessed by MiniMental test requiring a participant to score \>24 (out of 30 max score) Right-handed as determined by research diagnostic criteria of the Edinburgh Handedness Inventory (Oldfield 1971) Self report of normal or corrected-to-normal vision Exclusion Criteria Psychiatric disorders, only those requiring treatment because the medications may affect brain activation Neurological disorder that may affect cognition, balance, and/or physical wellness such as brain injury, or stroke. Orthopedic injuries or neuromuscular disorder that may affect balance or mobility Engagement in other cognitive or physical training program while enrolled in this study Ongoing relapse (new or returning neurological symptoms) or steroid treatment during the 30 days preceding enrollment

Study sites (1)

NJ