An interventional study of Transcutaneous spinal cord stimulator and Epidural spinal cord stimulator system in Paraplegia, Spinal, Paraplegia, Complete and Paraplegia; Traumatic, sponsored by Kristin Zhao, PhD. Withdrawn. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Kristin Zhao, PhD · Not applicable, Interventional, and Basic science
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.
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.
151 studies on the registry are indexed under Paraplegia; 36 are open to participants now.
Browse Paraplegia studies →Kristin Zhao, PhD is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Transcutaneous spinal cord stimulator · Device: Epidural spinal cord stimulator system
DS8R Electrical Stimulator For Human Research
Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead
Kinematics
Change in measurements of joint angles, measured in degrees.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Electromyography
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
Foot pressure
Change in measurements of foot pressure through shoe-insole pressure sensors.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Monosynaptic spinal reflex testing
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
Trunk stability
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
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Bone mineral density
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
Body composition - body fat mass
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
Body composition - lean mass
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
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Body composition - bone mass
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
Metabolics - CBC
Measurement of changes in complete blood count with differential.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - glucose
Measurement of change in fasting glucose value.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - total cholesterol
Measurement of change in total cholesterol value.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - HDL cholesterol
Measurement of change in HDL cholesterol value.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - calculated LDL cholesterol
Measurement of change in calculated LDL cholesterol value.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - triglycerides
Measurement of change in triglycerides value.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - non-HDL cholesterol
Measurement of change in non-HDL cholesterol value.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Neurostimulator array location and migration
Evaluation of current array location via CT.
Time frame: Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Volitional movement (1)
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
Volitional movement (2)
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
Volitional movement (3)
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
Volitional movement (4)
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
Volitional movement (5)
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
Volitional movement (6)
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
Volitional movement (7)
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
Volitional movement (8)
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
Overground ambulation [as appropriate to the subject] (1)
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
Overground ambulation [as appropriate to the subject] (2)
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
Overground ambulation [as appropriate to the subject] (3)
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
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2022; primary completion for Dec 2025, 36 months later.
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This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Kristin Zhao, PhD