No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
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At a Glance
Age
22 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
14 (estimated)
Sponsor
Cionic, Inc. · Industry
Who this trial is looking for
This trial is looking for people with multiple sclerosis who can walk for at least 15 minutes a day. Participants will use a device called the Cionic Neural Sleeve to see if it improves mobility.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 22 and 75 years old.
I have relapsing-remitting or progressive multiple sclerosis.
I can walk for at least 15 minutes a day for five days a week.
I have enough cognitive skills to understand instructions.
I can tolerate wearing the Neural Sleeve for up to 8 hours a day.
My timed walking score is between 8 and 45 seconds.
I have not changed my medication or had a worsening of symptoms in the last 60 days.
My disease steps score is between 3 and 5 or my EDSS score is between 4 and 6.5.
You may not be able to join if
I have lower motor neuron disease or an injury that affects my response to stimulation.
I have no sensation in my affected leg.
I cannot achieve muscle contractions with the stimulation.
I cannot walk while using the Neural Sleeve.
I have fallen more than once a week.
I have not used FES devices in the past year.
I have a demand-type cardiac pacemaker or defibrillator.
I have a malignant tumor or existing thrombosis in my affected leg.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).
Trial Locations
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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 Telep…
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
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