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

Completed · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02252666

Run by

University of Wisconsin, Madison

People needed

6

Starts

2014-03-01

Expected to finish

2017-06-28

Last updated by the study team

2019-07-09

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• TCNL, 455 Science Drive, Suite 165 — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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