Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964829
• Other study ID #: CIONIC-06-001
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Cionic, Inc.
• Contact: Douglas A Wajda, PhD
• Phone: 3308837149
• Email: d.a.wajda[@]csuohio.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

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.
• Actigraph accelerometer
Physical activity will be recorded using an Actigraph accelerometer worn on the non-dominant hip.

Locations

Country	Name	City	State
United States	Cleveland State University	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cionic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Health-Related Quality of Life	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.	Day 0, Week 6, Week 12
Other	Change in Impact of MS	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.	Day 0, Week 6, Week 12
Other	Change in Perceived Fatigue	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.	Day 0, Week 6, Week 12
Other	Change in Spasticity	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.	Week 1, Week 6, Week 12
Other	Change in Lower Limb Strength	Strength assessment of the ankle dorsiflexors, hamstrings, and quadriceps muscles using a handheld dynamometer in seated or laying in prone, measured in Newtons.	Week 1, Week 6, Week 12
Other	Change in Ankle Plantarflexor Strength	Ankle plantarflexor strength will be measured by maximal repetitions of single leg heel raises.	Week 1, Week 6, Week 12
Other	Change in Lower Limb Range of Motion	Range of motion of the ankle, knee, and hips will be assessed by a trained clinician using a handheld goniometer.	Week 1, Week 6, Week 12
Other	Change in Walking Endurance	Measured via the 6-minute walk test, where subjects will walk as far as possible for 6 minutes, measured in meters.	Week 1, Week 6, Week 12
Other	Change in Balance	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.	Week 1, Week 6, Week 12
Other	Change in Blood Lipids	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.	Week 1, Week 6, Week 12
Other	Change in Blood Glucose	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.	Week 1, Week 6, Week 12
Other	Change in Incidence of Falls	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.	From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Other	Change in Medication(s) and Dosage	Measured by changes in dose intensities of prescribed medication(s).	Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16
Other	Change in Pain	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.	Week 1, Week 6, Week 12
Other	Change in Self-Reported Physical Activity	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.	From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Primary	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.	Week 1, Week 6, Week 12
Primary	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.	Week 1, Week 6, Week 12
Primary	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.	Day 0, Week 6, Week 12
Primary	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.	Week 1, Week 6, Week 12
Primary	Amount of Daily Walking/Activity Level	Collected by the usage log of the device(s), measured in steps per day	Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Primary	Duration of Daily Walking/Activity Level	Collected by the usage log of the device(s), measured in duration of activity.	Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16