Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT05964829
• Recruitment Status: Recruiting
• First Posted: July 28, 2023
• Last Update Posted: February 7, 2024
• Sponsor: Cionic, Inc.
• Information provided by (Responsible Party): Cionic, Inc.

Tracking Information

• First Submitted Date: July 18, 2023
• First Posted Date: July 28, 2023
• Last Update Posted Date: February 7, 2024
• Actual Study Start Date: September 4, 2023
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2023)

• Change in Gait Speed [ Time Frame: Week 1, Week 6, Week 12 ]
  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 [ Time Frame: Week 1, Week 6, Week 12 ]
  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 [ Time Frame: Day 0, Week 6, Week 12 ]
  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 [ Time Frame: Week 1, Week 6, Week 12 ]
  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 [ Time Frame: Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16 ]
  Collected by the usage log of the device(s), measured in steps per day
• Duration of Daily Walking/Activity Level [ Time Frame: Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16 ]
  Collected by the usage log of the device(s), measured in duration of activity.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: July 25, 2023)

• Change in Health-Related Quality of Life [ Time Frame: Day 0, Week 6, Week 12 ]
  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.
• Change in Impact of MS [ Time Frame: Day 0, Week 6, Week 12 ]
  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.
• Change in Perceived Fatigue [ Time Frame: Day 0, Week 6, Week 12 ]
  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.
• Change in Spasticity [ Time Frame: Week 1, Week 6, Week 12 ]
  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.
• Change in Lower Limb Strength [ Time Frame: Week 1, Week 6, Week 12 ]
  Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.
• Change in Ankle Plantarflexor Strength [ Time Frame: Week 1, Week 6, Week 12 ]
  Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.
• Change in Lower Limb Range of Motion [ Time Frame: Week 1, Week 6, Week 12 ]
  Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.
• Change in Walking Endurance [ Time Frame: Week 1, Week 6, Week 12 ]
  Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.
• Change in Balance [ Time Frame: Week 1, Week 6, Week 12 ]
  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.
• Change in Blood Lipids [ Time Frame: Week 1, Week 6, Week 12 ]
  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.
• Change in Blood Glucose [ Time Frame: Week 1, Week 6, Week 12 ]
  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.
• Change in Incidence of Falls [ Time Frame: From enrollment to end of treatment at 12 weeks, post-intervention at Week 16 ]
  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.
• Change in Medication(s) and Dosage [ Time Frame: Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16 ]
  Measured by changes in dose intensities of prescribed medication(s).
• Change in Pain [ Time Frame: Week 1, Week 6, Week 12 ]
  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.
• Change in Self-Reported Physical Activity [ Time Frame: From enrollment to end of treatment at 12 weeks, post-intervention at Week 16 ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Chronic Progressive

Intervention

• Device: Cionic Neural Sleeve NS-100
  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.
• Device: Actigraph accelerometer
  Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.

Study Arms

• Experimental: Control
  Participants will follow the walking program.
  Intervention: Device: Actigraph accelerometer
• Experimental: Functional electrical stimulation
  Participants will follow the walking program and receive stimulation assistance during the walking sessions.
  Interventions:

  • Device: Cionic Neural Sleeve NS-100
  • Device: Actigraph accelerometer

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 25, 2023): 6
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Douglas A Wajda, PhD; 3308837149; d.a.wajda@csuohio.edu

Contact: Rebecca Webster, PhD; 925-788-6649; rebecca@cionic.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05964829
• Other Study ID Numbers: CIONIC-06-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cionic, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Cionic, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Douglas A Wajda, PhD; Cleveland State University

• PRS Account: Cionic, Inc.
• Verification Date: February 2024