Evaluating Intervention Responsiveness in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title: Evaluating Intervention Responsiveness in People With Multiple Sclerosis

Status Completed

Clinical Trial Summary

The purpose is to see how multiple sclerosis (MS) is associated with strength and sensation using MRI, in persons with MS. The investigators will also see whether exercise can improve these symptoms for persons with MS.

Clinical Trial Description

Multiple sclerosis (MS) is a chronic inflammatory disorder that damages myelin sheaths and axons in the brain and spinal cord. Within ten years of being diagnosed with MS, a majority of people will experience disability, most often walking impairments. The currently available pharmacologic treatments offer protection from new attacks but do not help with recovery; thus, in many cases the only hope for improvement, is through physical rehabilitation.

Rehabilitative interventions, such as progressive resistance training (PRT), have been shown to improve strength and sometimes walking in many individuals with MS. However, there are also many individuals who do not respond, which tends to be ignored in the literature. In addition, most intervention studies measure the primary impairment (e.g, strength) with little or no consideration for other impairments (e.g., sensory loss) and any effects on more complicated movements (e.g. standing, or changing direction). Since MS is so heterogeneous, it would be helpful to know which individuals are likely to benefit from rehabilitation.

Standard MS care uses MRI for diagnosis, identification of inflammatory lesions, and determination of treatment efficacy. Conventional rehabilitation relies on clinical judgment, rating scales and impairment measures to determine treatment efficacy. The investigators would like to understand how behavioral impairments and MRI findings relate to each other, and predict rehabilitation potential for people with MS. The investigators have previously shown that damage measured using tract specific MRI, specifically magnetization transfer (MTI) and diffusion tensor imaging (DTI), correlates with physical impairments in individuals with MS. Here the investigators propose to determine whether measures of clinical impairment and tract specific MRI can improve our ability to predict who will respond best to a PRT exercise intervention by improving functional movement. The investigators will perform a PRT intervention. The investigators will measure sensory and motor impairments and walking ability before and after the intervention. MRI will be done before treatment to assess the integrity of critical motor (corticospinal, CST) and sensory (dorsal column-medial lemniscus, DC-ML) tracts across the cervical spinal cord and brain. The investigators hypothesize that a combination of impairment measures and MRI measure will predict improvement in functional movement following three months of PRT. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT01632293
• Study type: Interventional
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Completion date: September 2015