Trial Outcomes & Findings for Impact of Direct Current Electrical Stimulation on Spasticity Levels and Functional Muscle Use in MS (NCT NCT04942938)
NCT ID: NCT04942938
Last Updated: 2025-07-04
Results Overview
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment.
COMPLETED
NA
7 participants
Baseline, Pre-intervention
2025-07-04
Participant Flow
Participant milestones
| Measure |
Neubie Treatment
Outcome measures will be collected at the beginning and end of study.
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
Neubie: The Neubie is a direct current neuromuscular electrical stimulation device. This system uses an exponential wave pattern to mimic the natural pattern neurologically to lengthen fibers of the sarcomere and engage force velocity of muscle with minimized protective co-contraction of nearby muscle groups. The golgi tendon and muscle spindles code for joint position and muscle/tendon stretch with 66% of fibers being intrafusal. Impacting these structures has direct impact on reticulospinal tract fibers and proprioceptive central fibers modulation of levels of spasticity. The Neubie direct current is designed to improve positioning of these stretch receptors.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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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
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=7 Participants
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Age, Categorical
Between 18 and 65 years
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7 Participants
n=7 Participants
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Age, Categorical
>=65 years
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0 Participants
n=7 Participants
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Age, Continuous
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45 years
STANDARD_DEVIATION 10 • n=7 Participants
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Sex: Female, Male
Female
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3 Participants
n=7 Participants
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Sex: Female, Male
Male
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4 Participants
n=7 Participants
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Region of Enrollment
United States
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7 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Pre-interventionThe Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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Expanded Disability Status Score
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6.8 score on a scale
Standard Deviation 0.8
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PRIMARY outcome
Timeframe: 6 weeksThe Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The neurologist did not measure any change in EDSS score for any of the 7 study subjects from her first assessment to her final second assessment.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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Expanded Disability Status Score
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6.8 score on a scale
Standard Deviation 0.8
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PRIMARY outcome
Timeframe: Baseline, Pre-interventionThe Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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12 Item MS Walking Scale
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0.89 percentage of a score on a scale
Standard Deviation 0.14
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PRIMARY outcome
Timeframe: 6 weeksThe Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation. A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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12 Item MS Walking Scale
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0.7 percentage of a score on a scale
Standard Deviation 0.28
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PRIMARY outcome
Timeframe: Baseline, Pre-interventionA standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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Manual Muscle Test
Psoas right
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4 score on a scale
Standard Deviation 2
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Manual Muscle Test
Psoas left
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4 score on a scale
Standard Deviation 3
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Manual Muscle Test
rectus abdominus
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4 score on a scale
Standard Deviation 2
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Manual Muscle Test
quadratus lumborum right
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4 score on a scale
Standard Deviation 1
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Manual Muscle Test
quadratus lumborum left
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5 score on a scale
Standard Deviation 2
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Manual Muscle Test
rectus femoris right
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4 score on a scale
Standard Deviation 2
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Manual Muscle Test
rectus femoris left
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5 score on a scale
Standard Deviation 2
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Manual Muscle Test
vastus lateralis and medialis right
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6 score on a scale
Standard Deviation 4
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Manual Muscle Test
vastus lateralis and medialis left
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6 score on a scale
Standard Deviation 3
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Manual Muscle Test
gluteus medius right
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5 score on a scale
Standard Deviation 2
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Manual Muscle Test
gluteus medius left
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5 score on a scale
Standard Deviation 3
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Manual Muscle Test
adductor group right
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6 score on a scale
Standard Deviation 2
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Manual Muscle Test
adductor group left
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6 score on a scale
Standard Deviation 2
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Manual Muscle Test
tibialis anterior right
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5 score on a scale
Standard Deviation 4
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Manual Muscle Test
tibialis anterior left
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6 score on a scale
Standard Deviation 4
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Manual Muscle Test
fibularii right
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6 score on a scale
Standard Deviation 4
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Manual Muscle Test
fibularii left
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6 score on a scale
Standard Deviation 4
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Manual Muscle Test
lumbar extension
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8 score on a scale
Standard Deviation 3
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Manual Muscle Test
gluteus maximus right
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4 score on a scale
Standard Deviation 3
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Manual Muscle Test
gluteus maximus left
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4 score on a scale
Standard Deviation 2
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PRIMARY outcome
Timeframe: 3 week measurementA standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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Manual Muscle Test
Psoas right
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3 units on a scale
Standard Deviation 2
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Manual Muscle Test
Psoas left
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4 units on a scale
Standard Deviation 2
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Manual Muscle Test
rectus abdominus
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4 units on a scale
Standard Deviation 1
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Manual Muscle Test
quadratus lumborum right
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5 units on a scale
Standard Deviation 3
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Manual Muscle Test
quadratus lumborum left
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4 units on a scale
Standard Deviation 2
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Manual Muscle Test
rectus femoris right
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3 units on a scale
Standard Deviation 2
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Manual Muscle Test
rectus femoris left
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4 units on a scale
Standard Deviation 2
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Manual Muscle Test
vastus lateralis and vastus medialis left
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6 units on a scale
Standard Deviation 3
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Manual Muscle Test
vastus lateralis and vastus medialis right
|
7 units on a scale
Standard Deviation 3
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Manual Muscle Test
gluteus medius right
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5 units on a scale
Standard Deviation 2
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Manual Muscle Test
gluteus medius left
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5 units on a scale
Standard Deviation 2
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Manual Muscle Test
adductor group right
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6 units on a scale
Standard Deviation 1
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Manual Muscle Test
adductor group left
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6 units on a scale
Standard Deviation 1
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Manual Muscle Test
tibialis anterior right
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3 units on a scale
Standard Deviation 3
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Manual Muscle Test
tibialis anterior left
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5 units on a scale
Standard Deviation 3
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Manual Muscle Test
fibularis right
|
3 units on a scale
Standard Deviation 3
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Manual Muscle Test
fibularis left
|
5 units on a scale
Standard Deviation 3
|
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Manual Muscle Test
lumbar extension
|
7 units on a scale
Standard Deviation 4
|
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Manual Muscle Test
gluteus maximus right
|
4 units on a scale
Standard Deviation 2
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Manual Muscle Test
gluteus maxiums left
|
4 units on a scale
Standard Deviation 2
|
PRIMARY outcome
Timeframe: 6 weeksA standardized set of assessments that measure strength. Scores are provided for each assessed muscle or muscle group individually in a scale from 0 to 5, in which 0 means no palpable muscle contraction, and 5 means a full range of motion capable of resisting 5 pounds of pressure. This scale of 5 includes values of (-) and (+) for each number which equals a total of 12. Data is entered on a 12-point scale here per requirements in data entry per clinical trials.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
|
Manual Muscle Test
psoas left
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6 units on a scale
Standard Deviation 2
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Manual Muscle Test
psoas right
|
4 units on a scale
Standard Deviation 2
|
|
Manual Muscle Test
rectus abdominus
|
5 units on a scale
Standard Deviation 1
|
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Manual Muscle Test
rectus femoris right
|
5 units on a scale
Standard Deviation 1
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Manual Muscle Test
rectus femoris left
|
5 units on a scale
Standard Deviation 3
|
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Manual Muscle Test
gluteus maxiumus left
|
5 units on a scale
Standard Deviation 3
|
|
Manual Muscle Test
biceps femoris right
|
6 units on a scale
Standard Deviation 2
|
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Manual Muscle Test
gluteus maximus right
|
6 units on a scale
Standard Deviation 3
|
|
Manual Muscle Test
biceps femoris left
|
6 units on a scale
Standard Deviation 2
|
|
Manual Muscle Test
tibialis anterior right
|
6 units on a scale
Standard Deviation 4
|
|
Manual Muscle Test
quadratus lumborum left
|
3 units on a scale
Standard Deviation 2
|
|
Manual Muscle Test
gluteus medius left
|
6 units on a scale
Standard Deviation 3
|
|
Manual Muscle Test
gluteus medius right
|
7 units on a scale
Standard Deviation 2
|
|
Manual Muscle Test
quadratus lumborum right
|
7 units on a scale
Standard Deviation 2
|
|
Manual Muscle Test
tibialis anterior left
|
7 units on a scale
Standard Deviation 3
|
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Manual Muscle Test
vastus lateralis/medialis right
|
8 units on a scale
Standard Deviation 3
|
|
Manual Muscle Test
hip adductor group right
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8 units on a scale
Standard Deviation 2
|
|
Manual Muscle Test
lumbar extension bilateral
|
8 units on a scale
Standard Deviation 3
|
|
Manual Muscle Test
vastus lateralis/medialis left
|
9 units on a scale
Standard Deviation 4
|
|
Manual Muscle Test
hip adductor group left
|
9 units on a scale
Standard Deviation 2
|
PRIMARY outcome
Timeframe: Baseline, Pre-interventionThe T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25 foot walk.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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Timed 25 Foot Walk Test (T25FW)
|
21.4 units on a scale (seconds)
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: baseline, pre-interventionThe Multiple sclerosis impact scale 29 (MSIS-29) is a 29-item assessment combining questions about the physical and psychological impact of the participant's condition on daily living. All items have Likert style response options that go from 1 (not at all) to 5 (extremely), where a total score of 145 indicates greater impact of disease on daily function (worse health), and the lower the score (The closer it is to 29), the smaller the impact of multiple sclerosis on the participant's daily function.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
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Multiple Sclerosis Impact Scale (MSIS-29)
|
97.3 percentage of a score on a scale
Standard Deviation 25.2
|
PRIMARY outcome
Timeframe: 3 weekThe T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25-foot walk measured in seconds. Higher second measures are slower and considered "worse" while lower second measures are faster and considered "better".
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
|
|---|---|
|
Timed 25 Foot Walk Test (T25FW)
|
20.7 seconds
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 6 weekThe T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25-foot walk measured in seconds. Higher second measures are slower and considered "worse" while lower second measures are faster and considered "better".
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
|
|---|---|
|
Timed 25 Foot Walk Test (T25FW)
|
15 seconds
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 6 weekThe Multiple sclerosis impact scale 29 (MSIS-29) is a 29-item assessment combining questions about the physical and psychological impact of the participant's condition on daily living. All items have Likert style response options that go from 1 (not at all) to 5 (extremely), where a total score of 145 indicates greater impact of disease on daily function (worse health), and the lower the score (The closer it is to 29), the smaller the impact of multiple sclerosis on the participant's daily function.
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
|
|---|---|
|
Multiple Sclerosis Impact Scale (MSIS-29)
|
85 percentage of a score on a scale
Standard Deviation 20.2
|
PRIMARY outcome
Timeframe: Baseline, pre-interventionThe Modified Ashworth Test is measured on a 5-point scale used to assess spasticity by grading the resistance encountered during passive muscle stretching. The assessor rates the perceived amount of resistance or tone encountered during the range of motion. 0=no tone detected 1+ = tone able to move through for less than half the range 2=tone able to move through for more than half the range 3=significant resistance to movement for entire range but able to break tone 4=completely rigid and unable to move limb
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
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|---|---|
|
Modified Ashworth Test
ankle dorsiflexion left
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
knee extension left
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
ankle dorsiflexion right
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
ankle plantarflexion right
|
3 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
knee extension right
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
ankle plantarflexion left
|
2 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip extension left
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip flexion left
|
0 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
knee flexion left
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip extension right
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip flexion right
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
knee flexion right
|
1 units on a scale
Standard Deviation 1
|
PRIMARY outcome
Timeframe: 6 weekThe Modified Ashworth Test is measured on a 5-point scale used to assess spasticity by grading the resistance encountered during passive muscle stretching. The assessor rates the perceived amount of resistance or tone encountered during the range of motion. 0=no tone detected 1+ = tone able to move through for less than half the range 2=tone able to move through for more than half the range 3=significant resistance to movement for entire range but able to break tone 4=completely rigid and unable to move limb
Outcome measures
| Measure |
Neubie Treatment
n=7 Participants
All participants in this study will participate in intervention treatment with the Neubie for 6 weeks. Outcome measures objective and subjective will be collected at the beginning and end of the study. The treatments will include:
1. Manual activations to underactive, spastic or limited in sensory muscles/regions
2. Neubie Mapping mode scanning process to scan for 1) spots that stimulate movement they couldn't do before per initial assessment, 2) spots that allow movement which is a greater range than available before per initial assessment, 3) spots that lead to decreased spasticity, and 4) diminished sensation areas - drive signal to increase sensory nerves and become metabolically active.
3. Train using physical therapy exercises with Neubie in training mode and Hz current adjusted for tolerance (perceived 7/10) and ability to work through or decrease spasticity in (500 Hz) in the areas which show spasticity, contraction, are dead/diminished sensation, and hot spots.
|
|---|---|
|
Modified Ashworth Test
ankle dorsiflexion left
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
knee extension left
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
ankle dorsiflexion right
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
ankle plantarflexion right
|
2 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
knee extension right
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
ankle plantarflexion left
|
2 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip extension left
|
1 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip flexion left
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
knee flexion left
|
0 units on a scale
Standard Deviation 1
|
|
Modified Ashworth Test
hip extension right
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
hip flexion right
|
0 units on a scale
Standard Deviation 0
|
|
Modified Ashworth Test
knee flexion right
|
1 units on a scale
Standard Deviation 1
|
Adverse Events
NeuBie Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NeuBie Treatment
n=7 participants at risk
The 7 subjects with Multiple Sclerosis participating in this clinical trial.
|
|---|---|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • 1 day
Adverse event collection match the clinicaltrials.gov definitions and procedures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place