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

NCT02252666 | Completed Results FDA Device

• 1 other identifier: 2013-1060
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

MS; balance; standing; control; movement

Outcome Measures

Primary Outcomes (1)

• Trunk Impairment Scale (TIS)

  Static and dynamic sitting balance and trunk coordination are evaluated by a clinician. It is scored on a scale from 0-23, where the higher the score, the more improved the balance. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a "small" effect size, 0.30 as a "medium" effect size, and 0.50 as a "large" effect size.

  Change from Baseline at 2, 6, 11, 16, and 21 weeks

Secondary Outcomes (17)

• Static Standing Balance Test

  Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks

• Impact of Visual Impairment Scale (IVIS)

  Change from Baseline at 2, 6, 11, 16, and 21 weeks

• Medical Outcomes Study (MOS) Pain Effects Scale (PES)

  Change from Baseline at 2, 6, 11, 16, and 21 weeks

• Bladder Control Scale (BLCS)

  Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks

• Bowel Control Scale (BWCS)

  Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks

Other Outcomes (1)

• Video Nystagmography (VNG)

  Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks

Study Arms (1)

Neuromodulation Rehabilitation

EXPERIMENTAL

Balance, posture and gait activities; therapeutic exercise for isolated muscle control; transfer training; and relaxation training using neurostimulation modulation. 2-week in lab intervention training, training at home and periodic return for follow-up testing and instruction on the next phase of the intervention.

Device: Neuromodulation Rehabilitation

Interventions

Neuromodulation Rehabilitation DEVICE

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.

Also known as: Cranial Nerve Non-invasive Neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)

Neuromodulation Rehabilitation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

TCNL, 455 Science Drive, Suite 165

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Mitchell Tyler
• Organization: University of Wisconsin - Madison

metyler1@wisc.edu

(608) 262-5112

Study Officials

• Mitchell E Tyler, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: September 30, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: June 28, 2017
• Last Updated: July 9, 2019
• Results First Posted: June 28, 2019

Record last verified: 2019-06

Locations

US (1)