Back to resultsImpact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cionic Neural Sleeve NS-100
Actigraph accelerometer
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75 Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia Able to tolerate the Neural Sleeve device for up to 8 hours per day T25FWT time between 8 and 45 seconds No recent change in medication or recent exacerbation of symptoms over the last 60 days Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5 Exclusion Criteria: Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation Absent sensation in the impacted or more impacted leg Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized History of falls greater than once a week No use of FES devices in the past year Demand-type cardiac pacemaker or defibrillator Malignant tumor in the impacted or more impacted leg Existing thrombosis in the impacted or more impacted leg Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
Sites / Locations
- Cleveland State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Functional electrical stimulation
Arm Description
Participants will follow the walking program.
Participants will follow the walking program and receive stimulation assistance during the walking sessions.
Outcomes
Primary Outcome Measures
Change in Gait Speed
The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.
Change in Perceived Walking Ability
Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.
Change in MS Disability
Expanded Disability Status Scale (EDSS), administered by a trained clinician, to quantify disability in MS and monitor changes in the level of disability over time. The EDSS scale ranges from 0 to 10, with high scores indicative of higher levels of disability.
Change in Fall Risk
Berg Balance Scale (BBS) to assess balance in 14 tasks, measured by score. Scores of the BBS range from 0 to 56, with 0-20 being wheelchair bound, 21-40 being walking with assistance, and 41-56 classified as independent.
Amount of Daily Walking/Activity Level
Collected by the usage log of the device(s), measured in steps per day
Duration of Daily Walking/Activity Level
Collected by the usage log of the device(s), measured in duration of activity.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05964829
Brief Title
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Official Title
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cionic, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Detailed Description
The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.
Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by an Actigraph; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS.
All participants will be assigned a hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study.
Participants will be randomized to one of two groups: A or B. Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve (intervention), while group B will only wear the Actigraph while walking. After 6 weeks, participants in each group will cross over to the other group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Participants will follow the walking program.
Arm Title
Functional electrical stimulation
Arm Type
Experimental
Arm Description
Participants will follow the walking program and receive stimulation assistance during the walking sessions.
Intervention Type
Device
Intervention Name(s)
Cionic Neural Sleeve NS-100
Intervention Description
The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Actigraph accelerometer
Intervention Description
Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.
Primary Outcome Measure Information:
Title
Change in Gait Speed
Description
The Timed 25-Foot Walk Test (T25FWT) to record duration of time to walk a distance of 25 feet, measured in seconds. The score is the average of two successive trials.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Perceived Walking Ability
Description
Multiple Sclerosis Walking Scale-12 (MSWS-12) to measure perceived impact of MS on walking ability, measured by score. Scores on the MSWS-12 range from 12-60 and transformed to a scale with a range from 0 to 100, with high scores indicative of a greater impact of MS on walking.
Time Frame
Week 1, Week 6, Week 12
Title
Change in MS Disability
Description
Expanded Disability Status Scale (EDSS), administered by a trained clinician, to quantify disability in MS and monitor changes in the level of disability over time. The EDSS scale ranges from 0 to 10, with high scores indicative of higher levels of disability.
Time Frame
Day 0, Week 6, Week 12
Title
Change in Fall Risk
Description
Berg Balance Scale (BBS) to assess balance in 14 tasks, measured by score. Scores of the BBS range from 0 to 56, with 0-20 being wheelchair bound, 21-40 being walking with assistance, and 41-56 classified as independent.
Time Frame
Week 1, Week 6, Week 12
Title
Amount of Daily Walking/Activity Level
Description
Collected by the usage log of the device(s), measured in steps per day
Time Frame
Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Title
Duration of Daily Walking/Activity Level
Description
Collected by the usage log of the device(s), measured in duration of activity.
Time Frame
Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Other Pre-specified Outcome Measures:
Title
Change in Health-Related Quality of Life
Description
The Euroqol 5 Dimension 5 Level (EQ-5D-5L) questionnaire describes health profiles using different domains, measured by a 5-digit code. Single-digit numbers of the dimensions range from 1 to 5, with 1 indicative of no problem and 5 indicative of extreme problems in that domain.
Time Frame
Day 0, Week 6, Week 12
Title
Change in Impact of MS
Description
Multiple Sclerosis Impact Scale-29 (MSIS-29) questionnaire to measure the physical and psychological impact of MS, measured by score. Scores on the MSIS-29 are transformed into a score out of 100, with higher scores indicative of greater degree of disability.
Time Frame
Day 0, Week 6, Week 12
Title
Change in Perceived Fatigue
Description
Modified Fatigue Impact Scale (MFIS) survey to measure the effects of fatigue in physical, cognitive, and psychosocial functioning. MFIS score ranges from 0 to 84, with high scores indicative of a greater impact of fatigue on activities.
Time Frame
Day 0, Week 6, Week 12
Title
Change in Spasticity
Description
A trained clinician will administer the Modified Ashworth Scale (MAS) to assess for muscle tone and spasticity. Scores of the MAS range from 0 to 4, with high scores representative of increased muscle tone and spasticity.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Lower Limb Strength
Description
Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Ankle Plantarflexor Strength
Description
Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Lower Limb Range of Motion
Description
Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Walking Endurance
Description
Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Balance
Description
Measured using force platform posturography in standing to quantify postural sway. There will be four 30-second trials with eyes open standing as still as possible.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Blood Lipids
Description
Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care lipid profile and cholesterol testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Blood Glucose
Description
Measured utilizing point of care analysis. The Cholestech LDX Analyzer provides accurate, actionable, and readily accessible results for point-of-care glucose testing, measured in milligrams per deciliter. Rapid, accurate results provide immediate awareness and identification of cardiovascular and diabetes health risks in only 5 minutes.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Incidence of Falls
Description
Measured using a self-reported fall diary and a survey, the Hopkins Fall Grading Scale, a 4-point scale to grade the nature and severity of a fall. Higher grades represent increased severity and impact of injurious falls.
Time Frame
From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Title
Change in Medication(s) and Dosage
Description
Measured by changes in dose intensities of prescribed medication(s).
Time Frame
Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16
Title
Change in Pain
Description
Measured using the questionnaire, the Numeric Pain Rating Scale (NPRS), an 11-point numeric scale ranging from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.
Time Frame
Week 1, Week 6, Week 12
Title
Change in Self-Reported Physical Activity
Description
Subjects will record their weekly physical activity using the Godin-Leisure Time Exercise Questionnaire (GLTEQ), measured by score. Scores less than 14 units are interpreted as insufficiently active/sedentary, while scores between 14 and 23 are interpreted as moderately active, and scores greater than 24 units are interpreted as active.
Time Frame
From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75
Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device
Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia
Able to tolerate the Neural Sleeve device for up to 8 hours per day
T25FWT time between 8 and 45 seconds
No recent change in medication or recent exacerbation of symptoms over the last 60 days
Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5
Exclusion Criteria:
Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
Absent sensation in the impacted or more impacted leg
Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation
Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
History of falls greater than once a week
No use of FES devices in the past year
Demand-type cardiac pacemaker or defibrillator
Malignant tumor in the impacted or more impacted leg
Existing thrombosis in the impacted or more impacted leg
Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas A Wajda, PhD
Phone
3308837149
Email
d.a.wajda@csuohio.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Webster, PhD
Phone
925-788-6649
Email
rebecca@cionic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas A Wajda, PhD
Organizational Affiliation
Cleveland State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland State University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas A Wajda
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
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