Paraplegia, SpinalService-LineNCT04627441
Transcutaneous and Epidural Stimulation in SCI
A study testing Transcutaneous spinal cord stimulator and Epidural spinal cord stimulator system in people with Paraplegia, Spinal and Paraplegia, Complete, run by Kristin Zhao, PhD.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Paraplegia, Spinal, Paraplegia, Complete, Paraplegia; Traumatic
- What is being tested?
- Transcutaneous spinal cord stimulator and Epidural spinal cord stimulator system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2022to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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.
About this study
Official title: A Pilot Study of the Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
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.
Read the 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.
- Being tested
- Transcutaneous spinal cord stimulator, Epidural spinal cord stimulator system
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulatorDevice
DS8R Electrical Stimulator For Human Research
Epidural spinal cord stimulator systemDevice
Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead
| Study group | Role | What they receive |
|---|---|---|
| TESS-EES | Experimental | 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. Receives: Device: Transcutaneous spinal cord stimulator; Device: Epidural spinal cord stimulator system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics
Change in measurements of joint angles, measured in degrees.
Measured: 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.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Foot pressure
Change in measurements of foot pressure through shoe-insole pressure sensors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - CBC
Measurement of changes in complete blood count with differential.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - glucose
Measurement of change in fasting glucose value.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - total cholesterol
Measurement of change in total cholesterol value.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - HDL cholesterol
Measurement of change in HDL cholesterol value.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - calculated LDL cholesterol
Measurement of change in calculated LDL cholesterol value.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - triglycerides
Measurement of change in triglycerides value.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - non-HDL cholesterol
Measurement of change in non-HDL cholesterol value.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Neurostimulator array location and migration
Evaluation of current array location via CT.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, End of TESS, Start of EES, End month 6 EES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start16 Dec 2022 (estimated)
- Primary completion16 Dec 2025 (estimated)
- Study completion16 Dec 2025 (estimated)
Why it stopped: COVID-related delays and insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraplegia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristin Zhao, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin D. Zhao, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627441
- Sponsor's protocol ID
- 20-006477
- Acronym
- Service-Line
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Characterization of Transcutaneous and Epidural Spinal Stimulation for Enabling Motor Function in Humans With Motor Complete Paraplegia
- ClinicalTrials.gov ID
- NCT04627441
- Acronym / sponsor ID
- Service-Line / 20-006477
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-related delays and insufficient funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kristin Zhao, PhDUniversity, hospital or other
- Study start
- 16 Dec 2022 (estimated)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TESS-EES | Experimental | Device: Transcutaneous spinal cord stimulator, Device: Epidural spinal cord stimulator systemTranscutaneous 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulatorDS8R Electrical Stimulator For Human Research | Device | TESS-EES |
| Epidural spinal cord stimulator systemSpectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead | Device | TESS-EES |
Primary outcome
Kinematics
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of joint angles, measured in degrees.
Electromyography
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of electrical activity at major muscle groups below the level of injury.
Foot pressure
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of foot pressure through shoe-insole pressure sensors.
Overground ambulation [as appropriate to the subject] (1)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of stimulation intensity H and F wave thresholds and maximal responses through surface electrodes.
Trunk stability
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Change in measurements of trunk stability using the modified functional reach test (mFRT).
Injury severity: American Spinal Injury Association (ASIA) Impairment Scale
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
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.
23 secondary outcomes
Spasticity
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Bone mineral density
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Body composition - body fat mass
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Body composition - lean mass
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Body composition - android and gynoid fat percentage
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Body composition - bone mass
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - CBC
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - glucose
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - total cholesterol
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - HDL cholesterol
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - calculated LDL cholesterol
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - triglycerides
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Metabolics - non-HDL cholesterol
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Neurostimulator array location and migration
Time frame: Start of EES, End month 6 EES
Patient-reported bowel function (1)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Patient-reported bowel function (2)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Patient-reported bladder function (1)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Patient-reported bladder function (2)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Male patient-reported sexual function (1)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Male patient-reported sexual function (2)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Male patient-reported sexual function (3)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Female patient-reported sexual function (1)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Female patient-reported sexual function (2)
Time frame: Baseline, End of TESS, Start of EES, End month 6 EES
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin D. Zhao, Ph.D. principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal cord stimulator and Epidural spinal cord stimulator system in people with Paraplegia, Spinal and Paraplegia, Complete, run by Kristin Zhao, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics (time frame: Baseline, End of TESS, Start of EES, End month 6 EES). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.