Reducing Symptoms of Multiple Sclerosis Using Non-invasive Neuromodulation
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study sought to examine the effect of targeted physical therapy with and without cranial
      nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who
      exhibited a dysfunctional gait.
    

Detailed description: 
      Background: This study sought to examine the effect of targeted physical therapy with and
      without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of
      people with MS who exhibited a dysfunctional gait. The investigators hypothesized that
      subjects who received electrical stimulation would have greater improvement than those who
      had a control device after a 14-week intervention. Gait disturbance is a common problem for
      people with multiple sclerosis (MS). The investigators have developed an effective
      rehabilitative strategy using neuromodulation of the cranial nerves via electrical
      stimulation of the tongue to enhance the plasticity of the brain.

      Methods: The study is a within-subject blinded randomized control design. Twenty chronic MS
      subjects with an identified gait disturbance were assigned to either an active or control
      group. Both groups completed a 14-week intervention program using a standardized combination
      of exercise and a device that provided electrical stimulation to the tongue. Those in the
      active group received electrical stimulation on the tongue that they could perceive. Those in
      the control group used a device that did not provide a physiologically significant stimulus
      and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).
    

Intervention name(s): Portable Neuromodulation Stimulator
Intervention type(s): Device
Intervention description(s): Examining the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibit a dysfunctional gait. Adopting a rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.
Other intervention name(s): PoNS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a within-subject blinded randomized control design. Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group. Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue. Those in the active group received electrical stimulation on the tongue that they could perceive.
Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable. Subjects were assessed with the Dynamic Gait Index (DGI).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Device Feasibility