Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The investigators hypothesis is that electrical stimulation to the tongue that directly
      stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural
      impulses to the brainstem and cerebellum. The investigators call this cranial nerve
      non-invasive neuromodulation (CN-NINM). The activation of these structures induces
      neuroplasticity when combined with specific physical exercises, can reduce symptoms of
      advanced MS, targeting primarily postural stability (sitting and standing), upper extremity
      movement, and ability to perform self-transfers.
    

Detailed description: 
      The intervention will be similar to that used in the investigators previous work with
      movement disorders, and will be tailored to the address issues unique to individuals with
      advanced MS.

      The study will enroll a total of 6 subjects having advanced MS that present with significant
      seated and standing balance, posture, or movement control deficits due to MS.

      Subjects will complete twice-daily lab training for two weeks (5 days/week). Each lab
      training (morning and afternoon) includes 1.5 to 2 hours of instruction in balance, posture
      and gait activities; therapeutic exercise for isolated muscle control; transfer training; and
      relaxation training.

      Activities are performed in 20-minute sessions with concomitant electrical stimulation of the
      tongue. The intervention is customized according to each subject's particular symptoms and
      tolerance. If a subject is not able to perform this amount of training, the training will be
      adapted to a level that is tolerable.

      After these 2 weeks, subjects will continue to perform these same intervention activities at
      home for 4 weeks. They will return to the lab for 1 week of training and testing, then
      perform home training for 4 weeks. This cycle is repeated for a total of 5 cycles.

      After the 6 months have been completed, subjects may choose to participate in an optional
      second phase of the study. The second phase includes an additional 12 months of participation
      in which subjects perform the intervention activities at home training and return to the lab
      on time per month for 2 hours of testing and 2 hours of training.

      If successful, this study would indicate that CN-NINM intervention may reduce the symptoms of
      advanced MS.
    

Intervention name(s): Neuromodulation Rehabilitation
Intervention type(s): Device
Intervention description(s): CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
Other intervention name(s): Cranial Nerve Non-invasive Neuromodulation (CN-NINM); Portable Neuromodulation Stimulator (PoNS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS; balance; standing; control; movement