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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02252666
First Posted: September 30, 2014
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention
Multiple Sclerosis Device: Neuromodulation Rehabilitation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Trunk Impairment Scale (TIS) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The TIS evaluates static and dynamic sitting balance, as well as trunk coordination.


Secondary Outcome Measures:
  • Static Standing Balance Test [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The Static Standing Balance Test measures standing balance in 5 conditions: feet 10 cm apart, feet together, stride stance, tandem stance, and single leg stance with eyes open and eyes closed.

  • Video Nystagmography (VNG) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    VNG is a standardized eye tracking test used to measure static and dynamic eye movement control to detect occulomotor abnormalities typically associated with degenerative neurological disorders, particularly in the brainstem and cerebellum. The subject wears goggles while an infrared video camera monitors and records eye movement as the eyes follow a dot on a computer screen.

  • Impact of Visual Impairment Scale (IVIS) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The IVIS is a self-report questionnaire that focuses on the ways in which MS-related visual problems affect everyday activities such as reading, watching television, recognizing house numbers, etc.

  • Medical Outcomes Study (MOS) Pain Effects Scale (PES) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The PES is a self-report questionnaire of the ways in which pain and unpleasant sensations interfere with mood, ability to walk or move, sleep, work, recreation, and enjoyment of life. It is particularly suitable to MS since it encompasses not just pain per se but other disturbing sensations often associated with MS such as burning, tingling, etc.

  • Bladder Control Scale (BLCS) and Bowel Control Scale (BWCS) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The BLCS and BWCS are self-report scales used to evaluate the impact of bowel and bladder control on lifestyle.

  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The RBANS is a brief, individually administered test that helps determine the neuropsychological status of adults ages 20 through 89 who have neurologic injury or disease such as dementia, head injury, and stroke. This tool consists of a battery of tests.

  • Walking Distance and Speed [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The Walking Distance and Speed test measures how far and fast the subject can walk until fatigue requires him/her to stop.

  • 12-item MS Walking Scale (MSWS-12) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The MSWS-12 is 12-item patient-rated questionnaire of the impact of MS on a person's walking.

  • Box & Blocks (B&B) assessment [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    B&B is a standardized clinical assessment of gross upper limb dexterity. Subjects move small blocks from one side of a box to the other within a time period (one minute). Each side is tested separately.

  • Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The MSIS-29 is a self-report questionnaire, measuring the physical and psychological impact of MS from the patient's perspective.

  • Modified Fatigue Impact Scale (MFIS) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The MFIS is a self-report questionnaire that assesses the perceived impact of fatigue on daily activities.

  • Gross Motor Function Measure (GMFM) [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The GMFM a standardized observational instrument that measures change in gross motor function. Subscales include lying & rolling; sitting; crawling & kneeling; standing; and walking, running & jumping.

  • Slump Test [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The Slump Test measures and quantifies changes in trunk control during functional sitting.

  • Modified Rivermead Mobility Index [ Time Frame: Change from Baseline at 2, 7, 12, 17, 22 and 27 weeks, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 months ]
    The Modified Rivermead Mobility Index is an 8 item assessment that quantifies the ability to perform transfers.


Enrollment: 6
Study Start Date: March 2014
Estimated Study Completion Date: March 2019
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neuromodulation Rehabilitation
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
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 Names:
  • Cranial Nerve Non-invasive Neuromodulation (CN-NINM)
  • Portable Neuromodulation Stimulator (PoNS)

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252666


Locations
United States, Wisconsin
TCNL, 455 Science Drive, Suite 165
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Mitchell E Tyler, MS University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02252666     History of Changes
Other Study ID Numbers: 2013-1060
First Submitted: July 15, 2014
First Posted: September 30, 2014
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by University of Wisconsin, Madison:
MS
balance
standing
control
movement

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases