Impact of Direct Current Electrical Stimulation on Spasticity Levels a
A Pilot Study of Neubie, a Direct Current Electrical Stimulation Device, to Inhibit Lower Extremity Spasticity Levels and Normalize Muscle Functional Use During Transfers and Ambulation in Individuals With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Neubie
Results by group
Expanded Disability Status Score
Baseline, Pre-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 6.8 score on a scale | 0.8 (Standard Deviation) | 7 |
Expanded Disability Status Score
6 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 6.8 score on a scale | 0.8 (Standard Deviation) | 7 |
12 Item MS Walking Scale
Baseline, Pre-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 0.89 percentage of a score on a scale | 0.14 (Standard Deviation) | 7 |
12 Item MS Walking Scale
6 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 0.7 percentage of a score on a scale | 0.28 (Standard Deviation) | 7 |
Manual Muscle Test
Baseline, Pre-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 4 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 score on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 4 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 score on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 5 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 5 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 5 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 5 score on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 5 score on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 6 score on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 8 score on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 4 score on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 4 score on a scale | 2 (Standard Deviation) | 7 |
Manual Muscle Test
3 week measurement
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 3 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 4 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 3 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 7 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 3 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 3 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 7 units on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 4 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 4 units on a scale | 2 (Standard Deviation) | 7 |
Manual Muscle Test
6 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 4 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 5 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 3 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 6 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 7 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 7 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 7 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 8 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 8 units on a scale | 2 (Standard Deviation) | 7 |
| Neubie Treatment | 8 units on a scale | 3 (Standard Deviation) | 7 |
| Neubie Treatment | 9 units on a scale | 4 (Standard Deviation) | 7 |
| Neubie Treatment | 9 units on a scale | 2 (Standard Deviation) | 7 |
Timed 25 Foot Walk Test (T25FW)
Baseline, Pre-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 21.4 units on a scale (seconds) | 5.2 (Standard Deviation) | 7 |
Multiple Sclerosis Impact Scale (MSIS-29)
baseline, pre-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 97.3 percentage of a score on a scale | 25.2 (Standard Deviation) | 7 |
Timed 25 Foot Walk Test (T25FW)
3 week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 20.7 seconds | 5.9 (Standard Deviation) | 7 |
Timed 25 Foot Walk Test (T25FW)
6 week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 15 seconds | 1.3 (Standard Deviation) | 7 |
Multiple Sclerosis Impact Scale (MSIS-29)
6 week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 85 percentage of a score on a scale | 20.2 (Standard Deviation) | 7 |
Modified Ashworth Test
Baseline, pre-intervention
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 3 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 2 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
Modified Ashworth Test
6 week
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 2 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 2 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 1 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 0 units on a scale | 0 (Standard Deviation) | 7 |
| Neubie Treatment | 1 units on a scale | 1 (Standard Deviation) | 7 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| NeuBie Treatment | 7 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Expanded Disability Status Score
Baseline, Pre-intervention
Disability progressionExpanded Disability Status Score
6 weeks
Disability progression12 Item MS Walking Scale
Baseline, Pre-intervention
Walking and mobility12 Item MS Walking Scale
6 weeks
Walking and mobilityManual Muscle Test
Baseline, Pre-intervention
Physical functionManual Muscle Test
3 week measurement
Physical functionManual Muscle Test
6 weeks
Physical functionTimed 25 Foot Walk Test (T25FW)
Baseline, Pre-intervention
Disability progressionWalking and mobilityMultiple Sclerosis Impact Scale (MSIS-29)
baseline, pre-intervention
Quality of life (reported by participants)Timed 25 Foot Walk Test (T25FW)
3 week
Disability progressionWalking and mobilityTimed 25 Foot Walk Test (T25FW)
6 week
Disability progressionWalking and mobilityMultiple Sclerosis Impact Scale (MSIS-29)
6 week
Quality of life (reported by participants)Modified Ashworth Test
Baseline, pre-intervention
SpasticityModified Ashworth Test
6 week
Spasticity
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
1. Greater than 18 years old (no upper age limit) 2. Physician diagnosed MS (As stated in Rooney S, et al. Disabil Rehabil. 2019, stage of MS did not impact individuals from making neuromuscular or functional gains. All stages of MS will be eligible) 3. Physician clearance to participate 4. Unable to ambulate more than 70 feet at a time and unable to ambulate outside the home, with use of manual chair or power chair as mobility source >= 50% of the time. 5. BLE MMT in hips, knees and ankles \<=3/5 6. Modified Ashworth assessed spasticity levels 1-4
Exclusion criteria
1. Co-morbidities in cardiovascular disease (myocardial infarction in past 1-year, unstable angina, CHF, h/o arrythmia, h/o CVA or TIA in past year, uncontrolled hypertension) 2. History of epileptic seizures 3. Lower Motor Neuron disease 4. Existing pacemaker, defibrillator or other implanted device (other than baclofen pump) 5. Unstable long bone fractures of lower limb or trunk 6. Allergies to surface electrodes or conductive gel 7. Pregnancy or actively seeking to become pregnant
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
In an individual with MS the central nervous system (CNS) is over-protective and causes the threshold for stretch reflex and muscle tightness to be set lower than normal. This inhibits normal movement and causes abnormalities in posture, stiffness and at times joint contractures. In this pilot study we hope to assess the ability for the direct current of Neubie, which creates mechanoreceptor inputs and lengthening at the sarcomere level of muscle and joints in the spine and lower extremity, to alter the proprioceptive peripheral nervous system (PNS) at muscle spindle and GTO level with a change in CNS over-guarding during the treatment and after the treatment. If the investigators are able to create normalized stretch and muscle tension at the PNS level, it may be possible to create temporary or sustained CNS level changes. This would allow the amount of stretch and tension at the PNS level to be normalized and possibly reduce spasticity. If this theory is accurate, the investigators may be able to increase access to normalized movement, strength and functional ability in individuals with neuro-compromise.
Papers
Background
Backus D, Burdett B, Hawkins L, Manella C, McCully KK, Sweatman M. Outcomes After Functional Electrical Stimulation Cycle Training in Individuals with Multiple Sclerosis Who Are Nonambulatory. Int J MS Care. 2017 May-Jun;19(3):113-121. doi: 10.7224/1537-2073.2015-036.Background
Etoom M, Khraiwesh Y, Lena F, Hawamdeh M, Hawamdeh Z, Centonze D, Foti C. Effectiveness of Physiotherapy Interventions on Spasticity in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2018 Nov;97(11):793-807. doi: 10.1097/PHM.0000000000000970.Background
Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080.Background
Szecsi J, Schlick C, Schiller M, Pollmann W, Koenig N, Straube A. Functional electrical stimulation-assisted cycling of patients with multiple sclerosis: biomechanical and functional outcome--a pilot study. J Rehabil Med. 2009 Jul;41(8):674-80. doi: 10.2340/16501977-0397.Background
Mills PB, Dossa F. Transcutaneous Electrical Nerve Stimulation for Management of Limb Spasticity: A Systematic Review. Am J Phys Med Rehabil. 2016 Apr;95(4):309-18. doi: 10.1097/PHM.0000000000000437.Background
Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R. Inter- and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Aug;54(4):576-590. doi: 10.23736/S1973-9087.17.04796-7. Epub 2017 Sep 13.
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History
Started
Jun 2021
Main results due
Jul 2022
Finished
Jul 2022
Results posted
Apr 2025