ParaplegiaNCT05095454
Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
A study testing Percutaneous epidural electrical spinal stimulation and Transcutaneous electrical spinal stimulation in people with Paraplegia and Tetraplegia, run by Kristin Zhao, PhD at 1 site in United States.
Trial summary
A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Paraplegia, Tetraplegia, Paralysis
- What is being tested?
- Percutaneous epidural electrical spinal stimulation and Transcutaneous electrical spinal stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 at or above the tenth thoracic vertebrae (T10)
- American Spinal Injury Association grading scale of A-D (2 from each) 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
- History of chronic and/or treatment resistant urinary tract infection
- Unhealed decubitus ulcer
- Unhealed skeletal fracture
- Untreated clinical diagnosis of depression
Show all 16Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury
A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.
Read the detailed description
The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.
- Conditions
- Paraplegia, Tetraplegia, Paralysis, Quadraplegia
- Being tested
- Percutaneous epidural electrical spinal stimulation, Transcutaneous electrical spinal stimulation
- Medical subject headings
- Paraplegia, Quadriplegia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous epidural electrical spinal stimulationDevice
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
Ripple Neuromed Nomad Neurostimulation System
Transcutaneous electrical spinal stimulationDevice
Digitimer DS8R Bipolar Constant Current Stimulator
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Epidural Stimulation | Experimental | 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. Receives: Device: Percutaneous epidural electrical spinal stimulation |
| Transcutaneous Epidural Stimulation | Experimental | Transcutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures. Receives: Device: Transcutaneous electrical spinal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
Change in voltage measurements in major muscle groups below the level of injury. Specifically, change in soleus root mean square voltage during standing with and without stimulation.
Measured: Through study completion; an average of 5 months.
Foot Pressure
Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.
Measured: Beginning of intervention to end of intervention, an average of 17 days.
Somatosensory Evoked Potentials
Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Transcranial Magnetic Stimulation Motor Evoked Potentials
Measurement of the threshold percentage change in voltage between pre-intervention and post-intervention in the first trapezius or deltoid muscle activated.
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury
Change sensory and motor function impairment using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete SCI) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Summed results produce overall sensory and motor scores and combine with evaluation of anal sensory and motor function in determination of AIS 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 scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of deep anal pressure and voluntary anal contraction are assessed as a yes/no; absence of these, in addition to sensory scores of 0 at S4-5 indicate a Complete injury (otherwise, the injury is Incomplete).
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Patient-reported Bowel Function
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. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Patient-reported Bladder Function
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. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Male Patient-reported Sexual Function (1)
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. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Male Patient-reported Sexual Function (2)
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. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Female Patient-reported Sexual Function
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: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.
Measured: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Neurostimulation User Experience
Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item.
Subscales grouping terms into like categories average scores into a 7 point range from -3 to +3, with negative averages associated with negative perceptions, and positive averages associated with positive perceptions.
Measured: End of intervention, an average of 4 weeks
Overground Ambulation [as Appropriate to the Subject]
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, 4 Weeks, 8 Weeks, and 20 Weeks
Trunk Stability
Changes in trunk stability based on stable forward reach measured in centimeters, with a greater distance of forward reach characterizing greater trunk stability. Specifically, change in forward reach at the end of the study when comparing stimulation assisted reach and non-stimulation assisted reach.
Measured: Beginning of intervention to end of intervention, an average of 17 days, 8 weeks post beginning of intervention, 20 weeks post beginning of intervention; change from beginning of intervention at week 20 reported.
Neurostimulator Lead Location and Migration [Epidural Group Only]
Evaluation of current array location via CT.
Measured: Pre-intervention and 4 weeks post-intervention
Bladder Function Testing
Change in measurements of bladder function (end fill detrusor value) utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.
Measured: Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start4 Mar 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParaplegiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT05095454
- Sponsor's protocol ID
- 21-006340
- Status last verified
- Jun 2024
- First submitted
- 3 Oct 2021
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Soong C, Veith DD, Gill ML, Beck LA, Block JB, Asp AJ, Fernandez KA, Linde MB, Mills CJ, Scrabeck TL, Jahanian O, Grahn PJ, Zhao KD, Solinsky R. Off-target effects of percutaneous epidural spinal cord and dorsal root ganglion stimulation with task-specific training on lower urinary tract function in individuals with chronic spinal cord injury. J Spinal Cord Med. 2026 Aug 20:1-12. doi: 10.1080/10790268.2026.2703371. Online ahead of print.
PubMed 42622482Veith DD, Gill ML, Beck LA, Whitmarsh CL, Fernandez KA, Linde MB, Asp AJ, Mills CJ, Bendel MA, Grahn PJ, Zhao KD. Functional outcomes and participants' perspectives during short-term application of spinal stimulation in individuals with spinal cord injury. J Spinal Cord Med. 2025 Nov;48(6):978-989. doi: 10.1080/10790268.2024.2383377. Epub 2024 Aug 22.
PubMed 39172032
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05095454
- Acronym / sponsor ID
- 21-006340
- Conditions
- Paraplegia, Tetraplegia, Paralysis, Quadraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kristin Zhao, PhDUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 9 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.
Detailed description
The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Epidural Stimulation | Experimental | Device: Percutaneous epidural electrical spinal stimulationEpidural 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. |
| Transcutaneous Epidural Stimulation | Experimental | Device: Transcutaneous electrical spinal stimulationTranscutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures. |
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 at or above the tenth thoracic vertebrae (T10)
- American Spinal Injury Association grading scale of A-D (2 from each) 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 (16 listed)
- Currently a prison inmate, or awaiting trial, related to criminal activity
- Pregnancy at the time of enrollment
- History of chronic and/or treatment resistant urinary tract infection
- Unhealed decubitus ulcer
- Unhealed skeletal fracture
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 |
|---|---|---|
| Percutaneous epidural electrical spinal stimulationAbbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System | Device | Percutaneous Epidural Stimulation |
| Transcutaneous electrical spinal stimulationDigitimer DS8R Bipolar Constant Current Stimulator | Device | Transcutaneous Epidural Stimulation |
Primary outcome
Electromyography
Time frame: Through study completion; an average of 5 months.
Change in voltage measurements in major muscle groups below the level of injury. Specifically, change in soleus root mean square voltage during standing with and without stimulation.
Foot Pressure
Time frame: Beginning of intervention to end of intervention, an average of 17 days.
Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.
Somatosensory Evoked Potentials
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.
Transcranial Magnetic Stimulation Motor Evoked Potentials
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Measurement of the threshold percentage change in voltage between pre-intervention and post-intervention in the first trapezius or deltoid muscle activated.
Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
Change sensory and motor function impairment using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete SCI) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Summed results produce overall sensory and motor scores and combine with evaluation of anal sensory and motor function in determination of AIS 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 scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of deep anal pressure and voluntary anal contraction are assessed as a yes/no; absence of these, in addition to sensory scores of 0 at S4-5 indicate a Complete injury (otherwise, the injury is Incomplete).
Patient-reported Bowel Function
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.
Patient-reported Bladder Function
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).
Male Patient-reported Sexual Function (1)
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.
Male Patient-reported Sexual Function (2)
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.
Female Patient-reported Sexual Function
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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.
Spasticity
Time frame: Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.
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. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.
Neurostimulation User Experience
Time frame: End of intervention, an average of 4 weeks
Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item. Subscales grouping terms into like categories average scores into a 7 point range from -3 to +3, with negative averages associated with negative perceptions, and positive averages associated with positive perceptions.
Overground Ambulation [as Appropriate to the Subject]
Time frame: Baseline, 4 Weeks, 8 Weeks, and 20 Weeks
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.
Trunk Stability
Time frame: Beginning of intervention to end of intervention, an average of 17 days, 8 weeks post beginning of intervention, 20 weeks post beginning of intervention; change from beginning of intervention at week 20 reported.
Changes in trunk stability based on stable forward reach measured in centimeters, with a greater distance of forward reach characterizing greater trunk stability. Specifically, change in forward reach at the end of the study when comparing stimulation assisted reach and non-stimulation assisted reach.
Neurostimulator Lead Location and Migration [Epidural Group Only]
Time frame: Pre-intervention and 4 weeks post-intervention
Evaluation of current array location via CT.
Bladder Function Testing
Time frame: Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
Change in measurements of bladder function (end fill detrusor value) utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42622482Soong C, Veith DD, Gill ML, Beck LA, Block JB, Asp AJ, Fernandez KA, Linde MB, Mills CJ, Scrabeck TL, Jahanian O, Grahn PJ, Zhao KD, Solinsky R. Off-target effects of percutaneous epidural spinal cord and dorsal root ganglion stimulation with task-specific training on lower urinary tract function in individuals with chronic spinal cord injury. J Spinal Cord Med. 2026 Aug 20:1-12. doi: 10.1080/10790268.2026.2703371. Online ahead of print.
- Derived from this study: PubMed 39172032Veith DD, Gill ML, Beck LA, Whitmarsh CL, Fernandez KA, Linde MB, Asp AJ, Mills CJ, Bendel MA, Grahn PJ, Zhao KD. Functional outcomes and participants' perspectives during short-term application of spinal stimulation in individuals with spinal cord injury. J Spinal Cord Med. 2025 Nov;48(6):978-989. doi: 10.1080/10790268.2024.2383377. Epub 2024 Aug 22.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous epidural electrical spinal stimulation and Transcutaneous electrical spinal stimulation in people with Paraplegia and Tetraplegia, run by Kristin Zhao, PhD at 1 site in United States.
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 16 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: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Electromyography (time frame: Through study completion; an average of 5 months.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095454, which also lists 2 linked publications.
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 9 Jul 2024.