N/A N=6 Treatment

Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS)

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT02252666 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Trunk Impairment Scale (TIS) — 0.82; 2.58; 1.47; 1.63 percentage of change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Neuromodulation Rehabilitation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Trunk Impairment Scale (TIS)	0.82; 2.58; 1.47; 1.63; 3.06	—
SECONDARY Static Standing Balance Test	0.90; 0.57; 1.04; 0.90; 0.49; 0.32	—
SECONDARY Impact of Visual Impairment Scale (IVIS)	1.27; 2.12; 3.54; 3.54; 2.12	—
SECONDARY Medical Outcomes Study (MOS) Pain Effects Scale (PES)	0.55; 0.64; 0.71; 0.40; 1.00	—
SECONDARY Bladder Control Scale (BLCS)	0.30; 0.30; 0.13; 0.41; 0.62; 0.27	—
SECONDARY Bowel Control Scale (BWCS)	1.20; 0.68; 0.52; 1.04; 0.86; 0.35	—
SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	-0.12; 0.39; 0.24; 0.78; 1.94; 0.51	—
SECONDARY Walking Distance	0.89; 0.75; 0.76; 0.69; 0.67; 0.26	—
SECONDARY Walking Speed	0.77; 0.84; 1.00; 1.01; -0.41; -0.94	—
SECONDARY 12-item MS Walking Scale (MSWS-12)	-0.50; 0.43; 0.87; 0.50; 1.33; -0.42	—
SECONDARY Box & Blocks (B&B) Assessment - Right	0.52; 0.45; 0.47; 1.17; 0.21; 4.95	—
SECONDARY Box & Blocks (B&B) Assessment - Left	0.07; 0.50; 0.80; 0.58; -0.04; 0.00	—
SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) - Physical	1.58; 0.61; 0.94; 0.89; 1.46; -0.71	—
SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) - Psychological	1.77; 1.17; 0.86; 0.98; 2.05; 0.35	—
SECONDARY Modified Fatigue Impact Scale (MFIS)	0.87; 3.10; 2.54; 1.75; 1.40; 0.20	—
SECONDARY Gross Motor Function Measure (GMFM)	0.82; 1.10; 1.19; 0.84; 0.16	—
SECONDARY Slump Test	—	—
SECONDARY Modified Rivermead Mobility Index	1.01; 1.21; 0.94; 1.44; 1.15; 0.38	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects must be age 18 or older.
Subjects will have a score between 6.5 to 7.5 on the Kurtzke Expanded Disability Status Scale (EDSS). The EDSS is a method of quantifying disability in people with multiple sclerosis.
Score of 6.5: needs constant bilateral support to walk 20 meters without resting.
Score of 7.0: unable to walk beyond five meters even with aid, and is essentially restricted to a wheelchair; wheels self and transfers alone, and is active in wheelchair about 12 hours a day.
Score of 7.5: unable to take more than a few steps and is restricted to wheelchair, and may need aid to transfer; wheels self, but may require a motorized chair for a full day's activities.
Subjects will have reached a plateau in an MS focused physical rehabilitation program in the 6 months prior to enrollment.
Requiring prior physical therapy will ensure that subjects have a core level of function that will allow them to participate in the study.
Requiring that subjects have reached a plateau will ensure that subjects' response to the intervention is due to the use of the device and not to the physical exercises alone.
Subjects who have participated in a physical rehabilitation program demonstrate that they are willing and able to commit to a rigorous training regimen.
Subjects will have a maximum score of 20 on the Trunk Impairment Scale (TIS). The TIS assesses static dynamic sitting balance and trunk coordination in a sitting position. A score of 20 or lower indicates that their ability to adequately maintain sitting posture is affected.
Subjects may have upper extremity involvement.
Subjects may have additional symptoms of nystagmus, dysarthria, sensory disturbance, pain, and/or bowel and bladder function. As they present, we will use appropriate assessments at baseline and successive study test points.
Subjects are their own legal guardians, and are able to understand and give informed consent.

Exclusion Criteria

Subjects will have no major co-morbidities, especially neurological disorders, uncontrolled pain, hypertension or diabetes. All subjects, if on medications, will not have had any major changes in type or dosage in within 3 months of enrollment. Additionally, candidates will be excluded if they:

have Functional Systems Scores (FSS) 4 or greater for pyramidal, cerebellar, brainstem, and sensory functions; 3 or greater for bowel and bladder function; and 2 or greater for cerebral function;
are able to walk independently;
use tobacco products (these activities tend to reduce tactile sensitivity in the oral cavity);
have any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months;
have a pacemaker, or are identified as at-risk for cardiovascular events;
have a history of seizures;
have a communicable disease;
have a biomechanical prosthetic;
are females who are pregnant.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02252666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.