Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS): in MS (type not specified), not a drug-phase study

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

CompletedNot a drug-phase studyMS (type not specified)NCT02252666

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Neuromodulation Rehabilitation

Results by group

Trunk Impairment Scale (TIS)

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

Group	Value	Number analysed
Neuromodulation Rehabilitation	0.82 percentage of change	4
Neuromodulation Rehabilitation	2.58 percentage of change	4
Neuromodulation Rehabilitation	1.47 percentage of change	4
Neuromodulation Rehabilitation	1.63 percentage of change	4
Neuromodulation Rehabilitation	3.06 percentage of change	4

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events	Deaths
Neuromodulation Rehabilitation	6	0 (0.0%)	0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Trunk Impairment Scale (TIS)
Change from Baseline at 2, 6, 11, 16, and 21 weeks
Walking and mobility

Other measures (17)

Static Standing Balance Test
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Walking and mobility
Impact of Visual Impairment Scale (IVIS)
Change from Baseline at 2, 6, 11, 16, and 21 weeks
Vision
Medical Outcomes Study (MOS) Pain Effects Scale (PES)
Change from Baseline at 2, 6, 11, 16, and 21 weeks
Walking and mobilityPainMood and sleep
Bladder Control Scale (BLCS)
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Bladder, bowel and sexual function
Bowel Control Scale (BWCS)
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Bladder, bowel and sexual function
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Walking Distance
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
FatigueWalking and mobility
Walking Speed
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Walking and mobility
12-item MS Walking Scale (MSWS-12)
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Walking and mobility
Box & Blocks (B&B) Assessment - Right
Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks
Arm and hand function

Who could take part

MS (type not specified) · 18 to 90

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

Started
Mar 2014
Main results due
Jan 2017
Finished
Jun 2017
Results posted
Jun 2019

Assembled by software from public sources.