Back to resultsTranscutaneous and Epidural Stimulation in SCI (Service-Line)
Primary Purpose
Paraplegia, Spinal, Paraplegia, Complete, Paraplegia; Traumatic
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous spinal cord stimulator
Epidural spinal cord stimulator system
Sponsored by
About this trial
This is an interventional basic science trial for Paraplegia, Spinal
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury due to trauma located between the seventh cervical (C7) and tenth thoracic vertebrae (T10)
- American Spinal Injury Association grading scale of A or B (4 each of A and B) below the level of SCI
- Intact spinal reflexes below the level of SCI
- At least 1-year post-SCI
- At least 22 years of age
- Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
Exclusion Criteria:
- Currently a prison inmate, or awaiting trial, related to criminal activity
- Pregnancy at the time of enrollment
- Dual energy x-ray absorptiometry (DEXA) t-score <-3.5 at spine and femur head
- History of chronic and/or treatment resistant urinary tract infection
- Unhealed decubitus ulcer
- Unhealed skeletal fracture
- Untreated clinical diagnosis of depression
- Presence of joint contractures or an Ashworth spasticity score of 4
- Active anti-spasticity medication regimen within 3 months prior to study enrollment
- Presence of transcranial magnetic stimulation-evoked potentials in leg muscles
- Undergoing, or planning to undergo, diathermy treatment
- Active participation in another interventional clinical trial
- Presence of conditions or disorders which require MRI monitoring
- A history of coagulopathy or other significant cardiac or medical risk factors for surgery
- Current use of a ventilator
- Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
- Mass > 113 kg (250 pounds)
- History of frequent hypotension characterized by light headedness, or loss of consciousness
- History of frequent hypertension characterized by headache, or bradycardia
- History of frequent, severe, autonomic dysreflexia
- Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TESS-EES
Arm Description
Transcutaneous Electrical Spinal Stimulation (TESS), used during the first month of training sessions, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.
Outcomes
Primary Outcome Measures
Kinematics
Change in measurements of joint angles, measured in degrees.
Electromyography
Change in measurements of electrical activity at major muscle groups below the level of injury.
Foot pressure
Change in measurements of foot pressure through shoe-insole pressure sensors.
Overground ambulation [as appropriate to the subject] (1)
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Overground ambulation [as appropriate to the subject] (2)
Measurement of changes in walking impairment as measured by the Walking Index for Spinal Cord Injury. Trainers will assess overall level of impairment, ranging from most severe impairment (0) to least severe impairment (20), based on the use of devices, braces, and physical assistance of one or more persons.
Somatosensory evoked potentials
Change in measurements of change in conduction in the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, through surface electrodes.
Transcranial magnetic stimulation motor evoked potentials
Change in measurements of stimulus intensity required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.
Monosynaptic spinal reflex testing
Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.
Trunk stability
Change in measurements of trunk stability using the modified functional reach test (mFRT).
Injury severity: American Spinal Injury Association (ASIA) Impairment Scale
Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of ASIA classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.
Secondary Outcome Measures
Spasticity
Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms.
Bone mineral density
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in bone mineral content and bone density.
Body composition - body fat mass
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total body fat mass.
Body composition - lean mass
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total lean mass.
Body composition - android and gynoid fat percentage
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total android and gynoid fat percentage.
Body composition - bone mass
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total bone mass.
Metabolics - CBC
Measurement of changes in complete blood count with differential.
Metabolics - glucose
Measurement of change in fasting glucose value.
Metabolics - total cholesterol
Measurement of change in total cholesterol value.
Metabolics - HDL cholesterol
Measurement of change in HDL cholesterol value.
Metabolics - calculated LDL cholesterol
Measurement of change in calculated LDL cholesterol value.
Metabolics - triglycerides
Measurement of change in triglycerides value.
Metabolics - non-HDL cholesterol
Measurement of change in non-HDL cholesterol value.
Neurostimulator array location and migration
Evaluation of current array location via CT.
Patient-reported bowel function (1)
Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms.
Patient-reported bowel function (2)
Measurement of change in bowel function using the International Spinal Cord Injury Bowel Function Basic Data Set (v2.0). Answers to qualitative questions are rated from 0 to 13, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes neurogenic bowel dysfunction.
Patient-reported bladder function (1)
Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms.
Patient-reported bladder function (2)
Assessment of change in bowel function using the International Spinal Cord Injury Urodynamic Basic Data Set. Data from various urodynamic variables are aggregated into a single-page format for an abstract overview of bladder dysfunction.
Male patient-reported sexual function (1)
Assessment of change in sexual function using the International Spinal Cord Injury Male Sexual Function Basic Data Set (v2.0). Data from various male sexual function variables are aggregated into a single-page format for an abstract overview of male sexual dysfunction.
Male patient-reported sexual function (2)
Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Male patient-reported sexual function (3)
Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Female patient-reported sexual function (1)
Assessment of change in sexual function using the International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set (v2.0). Data from various female sexual and reproductive function variables are aggregated into a single-page format for an abstract overview of female sexual and reproductive dysfunction.
Female patient-reported sexual function (2)
Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04627441
Brief Title
Transcutaneous and Epidural Stimulation in SCI
Acronym
Service-Line
Official Title
A Pilot Study of the Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-related delays and insufficient funding.
Study Start Date
December 16, 2022 (Anticipated)
Primary Completion Date
December 16, 2025 (Anticipated)
Study Completion Date
December 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study seeks to improve the scientific understanding of how two electrical stimulation techniques, one which delivers electricity to the skin surface over the spine (transcutaneous electrical spinal stimulation [TESS]) and another which is implanted onto the dura mater of the spinal cord (epidural electrical stimulation [EES]), facilitate spinal circuitry to enable function after SCI.
Detailed Description
The study will compare motor activity and clinical outcomes over the course of TESS and EES in combination with physical rehabilitation.
The primary outcome data collected will be used to characterize and compare spinal sensorimotor activity in muscles below the level of injury during TESS and EES-enabled motor tasks in persons with chronic motor complete paralysis of the lower extremities due to traumatic SCI. Furthermore, data collected will be used as a proof of concept that TESS can be used to determine recovery of function during EES-enabled motor tasks. Following exposure to each stimulation intervention, data collection will include changes to spasticity, body composition, metabolic variables, and spinal imaging to assess the effect of either TESS or EES stimulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia, Spinal, Paraplegia, Complete, Paraplegia; Traumatic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TESS-EES
Arm Type
Experimental
Arm Description
Transcutaneous Electrical Spinal Stimulation (TESS), used during the first month of training sessions, followed by Epidural Electrical Stimulation (EES) during the final 6-month training period.
Intervention Type
Device
Intervention Name(s)
Transcutaneous spinal cord stimulator
Intervention Description
DS8R Electrical Stimulator For Human Research
Intervention Type
Device
Intervention Name(s)
Epidural spinal cord stimulator system
Intervention Description
Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead
Primary Outcome Measure Information:
Title
Kinematics
Description
Change in measurements of joint angles, measured in degrees.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Electromyography
Description
Change in measurements of electrical activity at major muscle groups below the level of injury.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Foot pressure
Description
Change in measurements of foot pressure through shoe-insole pressure sensors.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Overground ambulation [as appropriate to the subject] (1)
Description
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Overground ambulation [as appropriate to the subject] (2)
Description
Measurement of changes in walking impairment as measured by the Walking Index for Spinal Cord Injury. Trainers will assess overall level of impairment, ranging from most severe impairment (0) to least severe impairment (20), based on the use of devices, braces, and physical assistance of one or more persons.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Somatosensory evoked potentials
Description
Change in measurements of change in conduction in the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, through surface electrodes.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Transcranial magnetic stimulation motor evoked potentials
Description
Change in measurements of stimulus intensity required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Monosynaptic spinal reflex testing
Description
Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Trunk stability
Description
Change in measurements of trunk stability using the modified functional reach test (mFRT).
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Injury severity: American Spinal Injury Association (ASIA) Impairment Scale
Description
Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of ASIA classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Secondary Outcome Measure Information:
Title
Spasticity
Description
Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Bone mineral density
Description
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in bone mineral content and bone density.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Body composition - body fat mass
Description
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total body fat mass.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Body composition - lean mass
Description
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total lean mass.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Body composition - android and gynoid fat percentage
Description
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total android and gynoid fat percentage.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Body composition - bone mass
Description
Measurement by dual-energy x-ray absorptiometry (DEXA) of change in regional and total bone mass.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - CBC
Description
Measurement of changes in complete blood count with differential.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - glucose
Description
Measurement of change in fasting glucose value.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - total cholesterol
Description
Measurement of change in total cholesterol value.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - HDL cholesterol
Description
Measurement of change in HDL cholesterol value.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - calculated LDL cholesterol
Description
Measurement of change in calculated LDL cholesterol value.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - triglycerides
Description
Measurement of change in triglycerides value.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Metabolics - non-HDL cholesterol
Description
Measurement of change in non-HDL cholesterol value.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Neurostimulator array location and migration
Description
Evaluation of current array location via CT.
Time Frame
Start of EES, End month 6 EES
Title
Patient-reported bowel function (1)
Description
Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Patient-reported bowel function (2)
Description
Measurement of change in bowel function using the International Spinal Cord Injury Bowel Function Basic Data Set (v2.0). Answers to qualitative questions are rated from 0 to 13, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes neurogenic bowel dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Patient-reported bladder function (1)
Description
Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Patient-reported bladder function (2)
Description
Assessment of change in bowel function using the International Spinal Cord Injury Urodynamic Basic Data Set. Data from various urodynamic variables are aggregated into a single-page format for an abstract overview of bladder dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Male patient-reported sexual function (1)
Description
Assessment of change in sexual function using the International Spinal Cord Injury Male Sexual Function Basic Data Set (v2.0). Data from various male sexual function variables are aggregated into a single-page format for an abstract overview of male sexual dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Male patient-reported sexual function (2)
Description
Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Male patient-reported sexual function (3)
Description
Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Female patient-reported sexual function (1)
Description
Assessment of change in sexual function using the International Spinal Cord Injury Female Sexual and Reproductive Function Basic Data Set (v2.0). Data from various female sexual and reproductive function variables are aggregated into a single-page format for an abstract overview of female sexual and reproductive dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Female patient-reported sexual function (2)
Description
Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Other Pre-specified Outcome Measures:
Title
Volitional movement (1)
Description
Measurement of change in volitional movement through recordings of training time in minutes.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (2)
Description
Measurement of change in volitional movement through recordings body weight support measured as a percentage of total body weight supported.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (3)
Description
Measurement of change in volitional movement through recordings of speed in miles per hour.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (4)
Description
Measurement of changes in volitional movement through recordings of assistive devices used.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (5)
Description
Measurement of changes in volitional movement through recordings of stimulator electrode location.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (6)
Description
Measurement of changes in volitional movement through recordings of stimulator intensity, measured in milliamps per volt.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (7)
Description
Measurements of changes in volitional movement through recordings of stimulator frequency measured in Hertz.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Volitional movement (8)
Description
Measurement of changes in volitional movement through recordings of pulse width, measured in microseconds.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Overground ambulation [as appropriate to the subject] (1)
Description
Measurement of changes in severity of walking impairment as measured by the Walking Index for Spinal Cord Injury (WISCI II). Trainers combine the type of assistive device(s) used, use or no use of orthotic braces, number of persons assisting ambulation, and distance subject is able to walk (up to 10 meters), into a single score ranging from 0 to 20, with a lower number indicating more severe impairment.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Overground ambulation [as appropriate to the subject] (2)
Description
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
Title
Overground ambulation [as appropriate to the subject] (3)
Description
Measurement of changes in overground mobility as measured by the Modified Timed Up and Go test. Trainers will assess the time it takes, in minutes and seconds, for the subject to stand from a chair, move out to a 3 meter distance, return to the chair and sit down. Less time will characterize better overground mobility.
Time Frame
Baseline, End of TESS, Start of EES, End month 6 EES
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury due to trauma located between the seventh cervical (C7) and tenth thoracic vertebrae (T10)
American Spinal Injury Association grading scale of A or B (4 each of A and B) below the level of SCI
Intact spinal reflexes below the level of SCI
At least 1-year post-SCI
At least 22 years of age
Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
Exclusion Criteria:
Currently a prison inmate, or awaiting trial, related to criminal activity
Pregnancy at the time of enrollment
Dual energy x-ray absorptiometry (DEXA) t-score <-3.5 at spine and femur head
History of chronic and/or treatment resistant urinary tract infection
Unhealed decubitus ulcer
Unhealed skeletal fracture
Untreated clinical diagnosis of depression
Presence of joint contractures or an Ashworth spasticity score of 4
Active anti-spasticity medication regimen within 3 months prior to study enrollment
Presence of transcranial magnetic stimulation-evoked potentials in leg muscles
Undergoing, or planning to undergo, diathermy treatment
Active participation in another interventional clinical trial
Presence of conditions or disorders which require MRI monitoring
A history of coagulopathy or other significant cardiac or medical risk factors for surgery
Current use of a ventilator
Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
Mass > 113 kg (250 pounds)
History of frequent hypotension characterized by light headedness, or loss of consciousness
History of frequent hypertension characterized by headache, or bradycardia
History of frequent, severe, autonomic dysreflexia
Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D. Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Transcutaneous and Epidural Stimulation in SCI
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