Spinal Cord InjuriesNCT04736849

Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

A study testing Percutaneous epidural and dorsal root stimulation in people with Spinal Cord Injuries and Paraplegia, run by Peter J. Grahn, Ph.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Spinal Cord Injuries, Paraplegia, Tetraplegia
What is being tested?: Percutaneous epidural and dorsal root stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2021to 19 Mar 2025
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
American Spinal Injury Association grading scale of A, B, C, or D
Intact spinal reflexes below the level of SCI
SCI must have occurred at least 1 year prior to study enrollment
At least 22 years of age
If female, must be willing to use medically-acceptable method of contraception during study participation

Who cannot join

Currently a prison inmate, or awaiting trial, related to criminal activity
Pregnancy at the time of screening for trial enrollment
Active, untreated urinary tract infection
Unhealed decubitus ulcer
Unhealed skeletal fracture
Spinal abnormality that may impede percutaneous implantation of spinal electrodes

Show all 16Show fewer

Untreated clinical diagnosis of psychiatric disorder
Joint contractures that impede typical range of motion
Non-MRI-compatible implanted medical devices
Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
Undergoing, or planning to undergo, diathermy treatment
Active participation in an interventional clinical trial
History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
History of frequent and/or severe autonomic dysreflexia
History of seizure disorder
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.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Read the detailed description

This study aims to expand the understanding of how electrical spinal stimulation enables function, specifically the pathophysiological mechanisms of action underlying spinal electrical stimulation after SCI, and to address the gap in knowledge of spinal sensorimotor network inputs and outputs generated by spinal electrical stimulation in humans with SCI.

Conditions: Spinal Cord Injuries, Paraplegia, Tetraplegia, Paralysis
Being tested: Percutaneous epidural and dorsal root stimulation
Medical subject headings: Spinal Cord Injuries, Paraplegia, Quadriplegia, Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous epidural and dorsal root stimulationDevice
Abbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350)
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874)
Ripple Neuromed Nomad Neurostimulation System

Study groups in NCT04736849
Study group	Role	What they receive
Percutaneous ES and DRS	Experimental	Epidural Stimulation (ES) and Dorsal Root Stimulation (DRS) will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of ES and DRS will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures. Receives: Device: Percutaneous epidural and dorsal root stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Electromyography
Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.
Measured: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).
Foot Pressure
Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation.
Measured: Assessed at Day 10 (end of intervention).
Somatosensory Evoked Potentials
Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve.
Measured: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Transcranial Magnetic Stimulation Motor Evoked Potentials
Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury.
Measured: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
American Spinal Injury Association Grading Scale
Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention.
Measured: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
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: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Modified Functional Reach Test
On Day 10 (end of intervention), trunk balance was assessed with and without stimulation during attempts to reach forward using the modified functional reach test.
Measured: Assessed at Day 10 (end of intervention).

Secondary outcomes (5)

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: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
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: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Male Patient-reported Sexual Function (SHIM)
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: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Male Patient-reported Sexual Function (IEF)
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: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
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.
Measured: Assessed at end of study ( after day 10 of intervention).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 202119 Mar 2025

First posted3 Feb 2021
Study start24 Sep 2021
Primary completion19 Mar 2025
Study completion19 Mar 2025

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 (1)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies 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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04736849
Sponsor's protocol ID: 20-006104
Other IDs: 1R01NS115877-01
Status last verified: Jun 2026
First submitted: 18 Dec 2020
Last updated: 16 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 42622482

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
ClinicalTrials.gov ID: NCT04736849
Acronym / sponsor ID: 20-006104
Conditions: Spinal Cord Injuries, Paraplegia, Tetraplegia, Paralysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Peter J. Grahn, Ph.D.University, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 24 Sep 2021 (actual)
Primary completion: 19 Mar 2025 (actual)
Study completion: 19 Mar 2025 (actual)
First posted: 3 Feb 2021 (actual)
Results: Posted 16 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Percutaneous ES and DRS	Experimental	Device: Percutaneous epidural and dorsal root stimulationEpidural Stimulation (ES) and Dorsal Root Stimulation (DRS) will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of ES and DRS 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
American Spinal Injury Association grading scale of A, B, C, or D
Intact spinal reflexes below the level of SCI
SCI must have occurred at least 1 year prior to study enrollment
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 screening for trial enrollment
Active, untreated 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 and dorsal root stimulationAbbott percutaneous trial lead for dorsal root ganglion neurostimulation (Model MN10350) Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Abbott clinician programmer for epidural and dorsal root ganglion neurostimulation (Model 3874) Ripple Neuromed Nomad Neurostimulation System	Device	Percutaneous ES and DRS

Primary outcome

Electromyography
Time frame: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).
Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.
Foot Pressure
Time frame: Assessed at Day 10 (end of intervention).
Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation.
Somatosensory Evoked Potentials
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve.
Transcranial Magnetic Stimulation Motor Evoked Potentials
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury.
American Spinal Injury Association Grading Scale
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention.
Spasticity
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
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.
Modified Functional Reach Test
Time frame: Assessed at Day 10 (end of intervention).
On Day 10 (end of intervention), trunk balance was assessed with and without stimulation during attempts to reach forward using the modified functional reach test.

5 secondary outcomes

Patient-reported Bowel Function
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Patient-reported Bladder Function
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Male Patient-reported Sexual Function (SHIM)
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Male Patient-reported Sexual Function (IEF)
Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).
Neurostimulation User Experience
Time frame: Assessed at end of study ( after day 10 of intervention).

Results and safety

Results posted to the registry on 16 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Motor Complete SCI	18	16
Cohort 2: Motor Incomplete SCI	4	4

Primary outcome: Electromyography

Time frame: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).. Mean (Standard Deviation). Unit: Percent change

Measure	Cohort 1: Motor Complete SCI n = 15	Cohort 2: Motor Incomplete SCI n = 4
Epidural stimulation	-51 (52)	-47 (39)
Dorsal root stimulation	-16 (16)	-15 (75)

Primary outcome: Foot Pressure

Time frame: Assessed at Day 10 (end of intervention).. Mean (Standard Deviation). Unit: Pounds of force

Measure	Cohort 1: Motor Complete SCI n = 2	Cohort 2: Motor Incomplete SCI n = 1
Stimulation off	34 (28)	50 (0)
Stimulation on	44 (39)	56.5 (0)

Primary outcome: Somatosensory Evoked Potentials

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).. Mean (Standard Deviation). Unit: microvolt

Measure	Cohort 1: Motor Complete SCI n = 15	Cohort 2: Motor Incomplete SCI n = 4
Left tibial nerve stimulation evoked response recorded from scalp	0.01 (0.13)	0.05 (0.1)
Right tibial nerve stimulation evoked response recorded from scalp	-0.17 (2.14)	-0.55 (1.1)

Primary outcome: Transcranial Magnetic Stimulation Motor Evoked Potentials

Time frame: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).. Mean (Standard Deviation). Unit: Percent

Measure	Cohort 1: Motor Complete SCI n = 12	Cohort 2: Motor Incomplete SCI n = 3
Value	-8 (22.6)	-20 (36.7)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end-of-study, approximately 3 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 18 (0%)	12 of 18 (66.7%)	0 of 18
Cohort 2	1 of 4 (25%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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.
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.

Peter J. Grahn, 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 and dorsal root stimulation in people with Spinal Cord Injuries and Paraplegia, run by Peter J. Grahn, Ph.D. 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 16 Jul 2026. 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 16 Jul 2026). 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: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).). The study lists 7 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 NCT04736849, which also lists 1 linked publication.

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 16 Jul 2026.