Impact of Direct Current Electrical Stimulation on Spasticity Levels and Functional Muscle Use in MS

NCT04942938 | Completed Results DMC FDA Device

• 1 other identifier: 1643900-2
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (14)

• Expanded Disability Status Score

  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.

  Baseline, Pre-intervention

• Expanded Disability Status Score

  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.

  6 weeks

• 12 Item MS Walking Scale

  The 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.

  Baseline, Pre-intervention

• 12 Item MS Walking Scale

  The 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.

  6 weeks

• Manual Muscle Test

  A 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.

  Baseline, Pre-intervention

• Manual Muscle Test

  A 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.

  3 week measurement

• Manual Muscle Test

  A 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.

  6 weeks

• Timed 25 Foot Walk Test (T25FW)

  The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in time, 25 foot walk.

  Baseline, Pre-intervention

• Multiple Sclerosis Impact Scale (MSIS-29)

  The 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.

  baseline, pre-intervention

• Timed 25 Foot Walk Test (T25FW)

  The 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".

  3 week

• Timed 25 Foot Walk Test (T25FW)

  The 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".

  6 week

• Multiple Sclerosis Impact Scale (MSIS-29)

  The 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.

  6 week

• Modified Ashworth Test

  The 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

  Baseline, pre-intervention

• Modified Ashworth Test

  The 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

  6 week

Study Arms (1)

Neubie Treatment

EXPERIMENTAL

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.

Device: Neubie

Interventions

Neubie DEVICE

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.

Neubie Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years old (no upper age limit)
• 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)
• Physician clearance to participate
• 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.
• BLE MMT in hips, knees and ankles \<=3/5
• Modified Ashworth assessed spasticity levels 1-4

You may not qualify if:

• 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)
• History of epileptic seizures
• Lower Motor Neuron disease
• Existing pacemaker, defibrillator or other implanted device (other than baclofen pump)
• Unstable long bone fractures of lower limb or trunk
• Allergies to surface electrodes or conductive gel
• Pregnancy or actively seeking to become pregnant

Sponsors & Collaborators

• CommonSpirit Health: lead
• NeuFit - Neurological Fitness and Education: collaborator

Study Sites (1)

Centura Health at Home

Littleton, Colorado, 80027, United States

Location

Related Publications (6)

• 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.

  PMID: 28603459 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.

  PMID: 29794531 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.

  PMID: 21138391 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.

  PMID: 19565162 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.

  PMID: 26829077 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.

  PMID: 28901119 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Courtney Ellerbusch
• Organization: Centura Health

courtneyellerbusch@centura.org

3039058272

Study Officials

• Courtney Ellerbusch, DPT

  CommonSpirit Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: This will be a pilot study using a series of 4-6 case studies for 4-6 participants. All studies will be completed entirely from the subject's home with CSHRI IRB oversight.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 29, 2021
• Study Start: June 20, 2021
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: July 4, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)