Spinal Cord InjuriesNCT07619300
Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage
A study testing Abbot Dorsal Root Ganglion Neurostimulator in people with Spinal Cord Injuries and Lower Motor Neuron Disease, run by Peter J. Grahn, Ph.D. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Lower Motor Neuron Disease
- What is being tested?
- Abbot Dorsal Root Ganglion Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Rochester, Minnesota, 55905
Peter J. Grahn, Ph.D., 507-316-5556, grahn.peter@mayo.edu
About this study
Official title: Pilot Study: Dorsal Root Ganglion Stimulation After Spinal Cord Injury-Related Lower Motor Neuron Damage
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.
- Conditions
- Spinal Cord Injuries, Lower Motor Neuron Disease
- Being tested
- Abbot Dorsal Root Ganglion Neurostimulator
- Medical subject headings
- Spinal Cord Injuries, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbot Dorsal Root Ganglion NeurostimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal Root Ganglion Stimulation | Experimental | One adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation. Receives: Device: Abbot Dorsal Root Ganglion Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 14 days
Secondary outcomes (3)
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.
Measured: Baseline, 14 days
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.
Measured: Baseline, 14 days
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.
Measured: Baseline, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter J. Grahn, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter J. Grahn, Ph.D., Mayo Clinic
- Investigators
- Peter J. Grahn, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619300
- Sponsor's protocol ID
- 26-003033
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 15 Sep 2026
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Dorsal Root Ganglion Stimulation After Spinal Cord Injury-Related Lower Motor Neuron Damage
- ClinicalTrials.gov ID
- NCT07619300
- Acronym / sponsor ID
- 26-003033
- Conditions
- Spinal Cord Injuries, Lower Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Peter J. Grahn, Ph.D.University, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Jun 2026 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dorsal Root Ganglion Stimulation | Experimental | Device: Abbot Dorsal Root Ganglion NeurostimulatorOne adult patient with spinal cord injury below T10 will be treated with dorsal root ganglion stimulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 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 |
|---|---|---|
| Abbot Dorsal Root Ganglion NeurostimulatorAfter 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. | Device | Dorsal Root Ganglion Stimulation |
Primary outcome
Change America Spinal Injury Association (ASIA) Impairment Scale categorization
Time frame: Baseline, 14 days
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.
3 secondary outcomes
Change in Neurogenic Bladder Symptom (NBSS) score
Time frame: Baseline, 14 days
Change in Neurogenic Bowel Dysfunction Survey (NBD) score
Time frame: Baseline, 14 days
Change in sexual function survey score
Time frame: Baseline, 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- 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.
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 Abbot Dorsal Root Ganglion Neurostimulator in people with Spinal Cord Injuries and Lower Motor Neuron Disease, 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 5 inclusion and 15 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: opening soon, as of the sponsor's last update on 15 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter J. Grahn, Ph.D. (507-316-5556, grahn.peter@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change America Spinal Injury Association (ASIA) Impairment Scale categorization (time frame: Baseline, 14 days). 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 15 Sep 2026.