Study Results
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View full resultsBasic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2023-09-11
2024-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Percutaneous Epidural Stimulation
Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Percutaneous epidural stimulation
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)
Ripple Neuromed Nomad Neurostimulation System
Interventions
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Percutaneous epidural stimulation
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)
Ripple Neuromed Nomad Neurostimulation System
Eligibility Criteria
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Inclusion Criteria
* No clinical or radiologic MS relapses for \> 5 years
* EDSS score of 6.5 (constant bilateral assistance required to walk about 20 meters without resting) as assessed by a Neurologist with a specialty in MS
* Able to ambulate 10 feet independently with or without gait aid use
* At least 22 years of age
* No changes to spasticity medications or dalfampridine over the last 3 months
Exclusion Criteria
* Pregnancy at the time of enrollment
* History of chronic and/or treatment resistant urinary tract infection
* Spasticity (grade of 4) measured bilaterally in two muscle groups using Modified Ashworth Scale (MAS). Muscle groups tested will include bilateral knee flexors, extensors; ankle plantarflexors, dorsiflexors
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Receiving diathermy treatment
* Active participation in an interventional clinical trial
* Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
* History of coagulopathy or other significant cardiac or medical risk factors for surgery
* Ventilator-dependent respiration
* Diagnosed with cardiopulmonary dysfunction (e.g., chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia)
* Untreated clinical diagnosis of depression
* History of frequent hypotension characterized by light headedness, or loss of consciousness
* History of frequent hypertension characterized by headache, or bradycardia
* Any active, implanted medical device
* Treatment of chemodenervation and/or neurolysis during the trial, or within 6 months of initiating the trial
22 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Kristin Zhao, PhD
OTHER
Responsible Party
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Kristin Zhao, PhD
Principal Investigator
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23-003967
Identifier Type: -
Identifier Source: org_study_id
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