Trial Outcomes & Findings for Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS) (NCT NCT02252666)
NCT ID: NCT02252666
Last Updated: 2019-07-09
Results Overview
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.
COMPLETED
NA
6 participants
Change from Baseline at 2, 6, 11, 16, and 21 weeks
2019-07-09
Participant Flow
Participant milestones
| Measure |
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.
Neuromodulation Rehabilitation: Cranial-nerve non-invasive neuromodulation (CN-NINM) uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exploring the Use of Non-invasive Neuromodulation Combined With Exercise in People With Advanced Multiple Sclerosis (MS)
Baseline characteristics by cohort
| Measure |
Neuromodulation Rehabilitation
n=6 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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5 Participants
n=5 Participants
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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5 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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6 participants
n=5 Participants
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Disease Chronicity
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17.7 years
STANDARD_DEVIATION 7.4 • n=5 Participants
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EDSS Score
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7.0 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
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MS Subtype
SPMS
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5 participants
n=5 Participants
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MS Subtype
PPMS
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, and 21 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Trunk Impairment Scale (TIS)
Baseline to Week 2
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0.82 percentage of change
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Trunk Impairment Scale (TIS)
Baseline to Week 6
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2.58 percentage of change
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Trunk Impairment Scale (TIS)
Baseline to Week 11
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1.47 percentage of change
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Trunk Impairment Scale (TIS)
Baseline to Week 16
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1.63 percentage of change
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Trunk Impairment Scale (TIS)
Baseline to Week 21
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3.06 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
Clinician measures standing balance for up to 30 seconds in each of 5 conditions: feet 10 cm apart, feet together, stride stance, tandem stance, and single leg stance with eyes open and eyes closed. Total score is the sum of all 5 conditions. Higher scores indicate better balance. Performance-based and tested in participants who possessed the ability to perform the assessment. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Static Standing Balance Test
Baseline to Week 2
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0.90 percentage of change
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Static Standing Balance Test
Baseline to Week 6
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0.57 percentage of change
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Static Standing Balance Test
Baseline to Week 11
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1.04 percentage of change
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Static Standing Balance Test
Baseline to Week 16
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0.90 percentage of change
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Static Standing Balance Test
Baseline to Week 21
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0.49 percentage of change
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Static Standing Balance Test
Baseline to Week 27
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0.32 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, and 21 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A 5-item self-report questionnaire that assesses the extent to which various activities dependent upon vision are affected by MS-related visual problems. Scores range from 0-15, with higher scores indicating a greater impact of visual problems on daily activities. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Impact of Visual Impairment Scale (IVIS)
Baseline to Week 2
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1.27 percentage of change
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Impact of Visual Impairment Scale (IVIS)
Baseline to Week 6
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2.12 percentage of change
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Impact of Visual Impairment Scale (IVIS)
Baseline to Week 11
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3.54 percentage of change
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Impact of Visual Impairment Scale (IVIS)
Baseline to Week 16
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3.54 percentage of change
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Impact of Visual Impairment Scale (IVIS)
Baseline to Week 21
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2.12 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, and 21 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A self-report scale that assesses the ways in which pain and unpleasant sensation interfere with mood, ability to walk or move, sleep, work, recreation, and enjoyment of life. This assessment is used for subjects who have pain. Scores can range from 6-30. Items are scaled so that higher scores indicate a greater impact of pain on a patient's mood and behavior. Symptom specific test, only used for participants who presented symptom. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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Medical Outcomes Study (MOS) Pain Effects Scale (PES)
Baseline to Week 2
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0.55 percentage of change
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Medical Outcomes Study (MOS) Pain Effects Scale (PES)
Baseline to Week 6
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0.64 percentage of change
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Medical Outcomes Study (MOS) Pain Effects Scale (PES)
Baseline to Week 11
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0.71 percentage of change
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Medical Outcomes Study (MOS) Pain Effects Scale (PES)
Baseline to Week 16
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0.40 percentage of change
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Medical Outcomes Study (MOS) Pain Effects Scale (PES)
Baseline to Week 21
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1.00 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A 4-item self-report scale to evaluate the impact of bladder control on lifestyle. This assessment is used for subjects with bladder issues. Scores can range from 0-22, with higher scores indicating greater bladder control problems. Symptom specific test, only used for participants who presented symptom. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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Bladder Control Scale (BLCS)
Baseline to Week 2
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0.30 percentage of change
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Bladder Control Scale (BLCS)
Baseline to Week 6
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0.30 percentage of change
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Bladder Control Scale (BLCS)
Baseline to Week 11
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0.13 percentage of change
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Bladder Control Scale (BLCS)
Baseline to Week 16
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0.41 percentage of change
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Bladder Control Scale (BLCS)
Baseline to Week 21
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0.62 percentage of change
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Bladder Control Scale (BLCS)
Baseline to Week 27
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0.27 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A 5-item self-report scale to evaluate the impact of bowel control on lifestyle. This assessment is used for subjects with bowel issues. Scores can range from 0-26, with higher scores indicating greater bowel control problems. Symptom specific test, only used for participants who presented symptom. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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Bowel Control Scale (BWCS)
Baseline to Week 2
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1.20 percentage of change
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Bowel Control Scale (BWCS)
Baseline to Week 6
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0.68 percentage of change
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Bowel Control Scale (BWCS)
Baseline to Week 11
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0.52 percentage of change
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Bowel Control Scale (BWCS)
Baseline to Week 16
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1.04 percentage of change
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Bowel Control Scale (BWCS)
Baseline to Week 21
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0.86 percentage of change
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Bowel Control Scale (BWCS)
Baseline to Week 27
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0.35 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A brief, clinician-administered test that helps determine the neuropsychological status of adults who have neurologic injury or disease such as dementia, head injury, and stroke. This tool consists of a battery of tests. Raw scores are transformed to a 0-120 scale, with a higher score indicating higher function. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline to Week 2
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-0.12 percentage of change
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline to Week 6
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0.39 percentage of change
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline to Week 11
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0.24 percentage of change
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline to Week 16
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0.78 percentage of change
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline to Week 21
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1.94 percentage of change
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline to Week 27
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0.51 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
Clinician measures how far the individual can walk until fatigue requires him/her to stop. Longer distances demonstrate improvement. Performance-based and tested in participants who possessed the ability to perform the assessment. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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Walking Distance
Baseline to Week 2
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0.89 percentage of change
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Walking Distance
Baseline to Week 6
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0.75 percentage of change
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Walking Distance
Baseline to Week 11
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0.76 percentage of change
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Walking Distance
Baseline to Week 16
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0.69 percentage of change
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Walking Distance
Baseline to Week 21
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0.67 percentage of change
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Walking Distance
Baseline to Week 27
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0.26 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
Assessed by timing the first 25 feet that the person walked. Performance-based and tested in participants who possessed the ability to perform the assessment. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Walking Speed
Baseline to Week 27
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-0.94 percentage of change
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Walking Speed
Baseline to Week 2
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0.77 percentage of change
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Walking Speed
Baseline to Week 6
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0.84 percentage of change
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Walking Speed
Baseline to Week 11
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1.00 percentage of change
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Walking Speed
Baseline to Week 16
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1.01 percentage of change
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Walking Speed
Baseline to Week 21
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-0.41 percentage of change
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SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A 12-item self-report measure of the impact of MS on a person's walking. Raw scores are transformed to a 0-100 scale. A reduction in score indicates improvement. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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12-item MS Walking Scale (MSWS-12)
Baseline to Week 11
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0.87 percentage of change
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12-item MS Walking Scale (MSWS-12)
Baseline to Week 27
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-0.42 percentage of change
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12-item MS Walking Scale (MSWS-12)
Baseline to Week 2
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-0.50 percentage of change
|
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12-item MS Walking Scale (MSWS-12)
Baseline to Week 6
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0.43 percentage of change
|
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12-item MS Walking Scale (MSWS-12)
Baseline to Week 16
|
0.50 percentage of change
|
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12-item MS Walking Scale (MSWS-12)
Baseline to Week 21
|
1.33 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
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. The score is the number of blocks moved from 0-150. A higher score indicates improvement. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
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|---|---|
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Box & Blocks (B&B) Assessment - Right
Baseline to Week 2
|
0.52 percentage of change
|
|
Box & Blocks (B&B) Assessment - Right
Baseline to Week 6
|
0.45 percentage of change
|
|
Box & Blocks (B&B) Assessment - Right
Baseline to Week 11
|
0.47 percentage of change
|
|
Box & Blocks (B&B) Assessment - Right
Baseline to Week 16
|
1.17 percentage of change
|
|
Box & Blocks (B&B) Assessment - Right
Baseline to Week 21
|
0.21 percentage of change
|
|
Box & Blocks (B&B) Assessment - Right
Baseline to Week 27
|
4.95 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
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. The score is the number of blocks moved from 0-150. A higher score indicates improvement. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Box & Blocks (B&B) Assessment - Left
Baseline to Week 16
|
0.58 percentage of change
|
|
Box & Blocks (B&B) Assessment - Left
Baseline to Week 27
|
0.00 percentage of change
|
|
Box & Blocks (B&B) Assessment - Left
Baseline to Week 2
|
0.07 percentage of change
|
|
Box & Blocks (B&B) Assessment - Left
Baseline to Week 6
|
0.50 percentage of change
|
|
Box & Blocks (B&B) Assessment - Left
Baseline to Week 11
|
0.80 percentage of change
|
|
Box & Blocks (B&B) Assessment - Left
Baseline to Week 21
|
-0.04 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A 29-item self-report tool that measures the impact of MS on day-to-day life. There are 3 scores, physical, psychological, and total score. Raw scores are transformed to a 0-100 scale. A higher score indicates a greater impact of disease on daily function. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Physical
Baseline to Week 2
|
1.58 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Physical
Baseline to Week 6
|
0.61 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Physical
Baseline to Week 11
|
0.94 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Physical
Baseline to Week 16
|
0.89 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Physical
Baseline to Week 21
|
1.46 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Physical
Baseline to Week 27
|
-0.71 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A 29-item self-report tool that measures the impact of MS on day-to-day life. There are 3 scores, physical, psychological, and total score. Raw scores are transformed to a 0-100 scale. A higher score indicates a greater impact of disease on daily function. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Psychological
Baseline to Week 2
|
1.77 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Psychological
Baseline to Week 6
|
1.17 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Psychological
Baseline to Week 11
|
0.86 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Psychological
Baseline to Week 16
|
0.98 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Psychological
Baseline to Week 21
|
2.05 percentage of change
|
|
Multiple Sclerosis Impact Scale (MSIS-29) - Psychological
Baseline to Week 27
|
0.35 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
A self-report tool that assesses the perceived impact of fatigue on daily activities. Consists of 21 items selected from the Fatigue Impact Scale. Scored on a 0-84 scale. A higher score indicates a greater impact of fatigue on daily activities. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Modified Fatigue Impact Scale (MFIS)
Baseline to Week 2
|
0.87 percentage of change
|
|
Modified Fatigue Impact Scale (MFIS)
Baseline to Week 6
|
3.10 percentage of change
|
|
Modified Fatigue Impact Scale (MFIS)
Baseline to Week 11
|
2.54 percentage of change
|
|
Modified Fatigue Impact Scale (MFIS)
Baseline to Week 16
|
1.75 percentage of change
|
|
Modified Fatigue Impact Scale (MFIS)
Baseline to Week 21
|
1.40 percentage of change
|
|
Modified Fatigue Impact Scale (MFIS)
Baseline to Week 27
|
0.20 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
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. For the complete test, the raw scores are converted to a 0-100 scale, with higher scores indicating greater functional mobility. The items that we used were scored on a 0-3 scale and changes reported in percent improvement. Performance-based and tested in participants who possessed the ability to perform the assessment. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Gross Motor Function Measure (GMFM)
Baseline to Week 6
|
0.82 percentage of change
|
|
Gross Motor Function Measure (GMFM)
Baseline to Week 11
|
1.10 percentage of change
|
|
Gross Motor Function Measure (GMFM)
Baseline to Week 16
|
1.19 percentage of change
|
|
Gross Motor Function Measure (GMFM)
Baseline to Week 21
|
0.84 percentage of change
|
|
Gross Motor Function Measure (GMFM)
Baseline to Week 27
|
0.16 percentage of change
|
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: The Slump Test was ultimately not used because the investigators decided to use the TIS instead. The TIS was realized to be the more appropriate assessment of the two, and the investigators wanted to avoid both data redundancy and test fatigue
Measures and quantifies changes in trunk control during functional sitting. It was quickly determined that this test duplicated the TIS and was difficult to score objectively so the decision was made not to use it for the study. Performance-based and tested in participants who possessed the ability to perform the assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.
An 8 item assessment that quantifies the ability to perform transfers. It has been validated in persons with stroke and a mixed neurologic population (43% MS). Score is a 0-40 scale. A higher score indicates higher function. Performance-based and tested in participants who possessed the ability to perform the assessment. 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.
Outcome measures
| Measure |
Neuromodulation Rehabilitation
n=4 Participants
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Modified Rivermead Mobility Index
Baseline to Week 2
|
1.01 percentage of change
|
|
Modified Rivermead Mobility Index
Baseline to Week 6
|
1.21 percentage of change
|
|
Modified Rivermead Mobility Index
Baseline to Week 11
|
0.94 percentage of change
|
|
Modified Rivermead Mobility Index
Baseline to Week 16
|
1.44 percentage of change
|
|
Modified Rivermead Mobility Index
Baseline to Week 21
|
1.15 percentage of change
|
|
Modified Rivermead Mobility Index
Baseline to Week 27
|
0.38 percentage of change
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from Baseline at 2, 6, 11, 16, 21 and 27 weeksPopulation: The VNG was exploratory and opportunistic. The results are not available as the software to perform the quantitative data analysis is still under development.
VNG is a standardized eye tracking test used to measure static and dynamic eye movement control to detect oculomotor 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.
Outcome measures
Outcome data not reported
Adverse Events
Neuromodulation Rehabilitation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neuromodulation Rehabilitation
n=6 participants at risk
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.
Neuromodulation Rehabilitation: CN-NINM uses sequenced patterns of electrical stimulation on the tongue. The hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
|
|---|---|
|
Injury, poisoning and procedural complications
Injury
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Trigeminal Neuralgia (TN)
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Viral Infection
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis Pain
|
16.7%
1/6 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place