ClinicalTrials.gg
Not yet recruitingNCT07619300Updated Sep 15, 2026

Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage

An interventional study of Abbot Dorsal Root Ganglion Neurostimulator in Spinal Cord Injuries and Lower Motor Neuron Disease, sponsored by Peter J. Grahn, Ph.D.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Peter J. Grahn, Ph.D. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 968 studies in Spinal Cord Injuries with a site in United States — 250 open to participants now, 308 under way, 7 of them phase 3. Spinal Cord Injuries · United States.

Planned enrollment
802nd of 836
1 · median 24
Started
2026
with 70 others
No phase
601 of 968
190 open now
Primary completion
2027-06
later than 150 of 307 live
Registered
939th of 968
by date

Among the 968 studies in Spinal Cord Injuries with a site in United States, this one is the 802nd largest by planned enrollment of the 836 interventional ones that give a count, is one of 71 that started in 2026, is one of 601 with no phase, reaches primary completion later than 150 of the 307 other live ones, and was the 939th registered.

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

250 of the 968 studies in Spinal Cord Injuries with a site in United States are open now. Recruiting first, the newest first:

245 more — sign in →

All 250 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to study sensorimotor circuit activity generated in response to temporarily implanted dorsal root ganglion stimulation by recording from muscles of the lower extremities as well as functional outcomes achieved over a 10-day rehabilitation program in an individual with lower motor neuron injury.

03

Conditions studied

  • Spinal Cord Injuries
  • Lower Motor Neuron Disease
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Traumatic and non-traumatic spinal cord injury (SCI)
  • ASIA Impairment Scale (AIS) A-D
  • SCI below the tenth thoracic vertebral level
  • Greater than 1 year post-SCI
  • Intact spinal reflexes at or below injury level in 1 or more muscles

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.)
  • Active participation in an interventional clinical trial which, based on the research team's assessment, may compromise protocol compliance, safety, and/or validity of data collected during this study
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (estimated)

Study arms

  • Experimental
    Dorsal Root Ganglion Stimulation

    One adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation.

    Device: Abbot Dorsal Root Ganglion Neurostimulator

Interventions

  • DeviceAbbot Dorsal Root Ganglion Neurostimulator

    After temporary implantation of leads into the dorsal root ganglia of lower spine, the patient will undergo 2-3 hour sessions over 10 days. Each session will consist of rehabilitation exercises will receiving electrical spinal stimulation.

06

What researchers measure

Primary outcomes

  1. Change America Spinal Injury Association (ASIA) Impairment Scale categorization

    The America Spinal Injury Association Impairment Scale is a provider assessment that categorizes spinal cord injuries into five distinct classifications, each representing different degrees of neurological impairment and functional preservation. Categories are defined as Grade A: complete impairment; Grade B: sensory but not motor function preserved; Grade C: motor function incomplete (most muscles): Grade D: motor function incomplete (half of key muscles); and Grade E: normal sensory and motor functions.

    Time frame: Baseline, 14 days

Secondary outcomes

  1. Change in Neurogenic Bladder Symptom (NBSS) score

    The Neurogenic Bladder Symptom Score (NBSS) survey a 24-item validated instrument that incorporates questions on bladder management, incontinence, storage, voiding and consequences and the impact on quality of life. Total scores range from 0 - 74, with higher scores indicating more severe bladder symptoms and dysfunction.

    Time frame: Baseline, 14 days

  2. Change in Neurogenic Bowel Dysfunction Survey (NBD) score

    The Neurogenic Bowel Dysfunction Survey (NBD) a validated questionnaire that incorporates several questions regarding fecal incontinence, constipation, obstruction, and impact on quality of life. Each of the 10 items on the NBD is weighted according to its importance on quality of life. Total scores range from 0 -47, with higher scores indicating more severe bowel dysfunction.

    Time frame: Baseline, 14 days

  3. Change in sexual function survey score

    International spinal cord injury female sexual and reproductive function basic data set (version 2.0) or International spinal cord injury male sexual function basic data set (version 2.0) will be used depending on subject enrolled. The survey asks the participant to answer 4 questions regarding sexual dysfunction as related to spinal cord injury, with answers on a scale of 0 = normal, 1 = reduced or altered, and 2 = absent. Higher scores indicate a greater level of impairment.

    Time frame: Baseline, 14 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 6 months is below that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2026
First posted
Jun 2, 2026
StartEst.
Dec 2026
Primary completionEst.
Jun 2027
CompletionEst.
Sep 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07619300
Lead sponsor
Peter J. Grahn, Ph.D.
Responsible party
Peter J. Grahn, Ph.D. (Principal Investigator, Mayo Clinic) — Sponsor-investigator
First posted
Jun 2, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Peter J. Grahn, Ph.D.
Contact
grahn.peter@mayo.edu
507-316-5556
Peter J. Grahn, Ph.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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