Spinal Cord InjuriesNCT07109804
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
A study testing Deep Brain Stimulation (DBS), Deep Brain Stimulation (DBS) Device Implant Procedure and Training Sessions in people with Spinal Cord Injuries, run by University of Miami at 2 sites in United States.
Trial summary
This is a study about deep brain stimulation (DBS) as an investigational treatment for walking impairment following spinal cord injury (SCI). The purpose of this study is to assess the feasibility and inform on the safety, and efficacy of CnF DBS to improve gait in SCI patients with incomplete injury who cannot… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Deep Brain Stimulation (DBS), Deep Brain Stimulation (DBS) Device Implant Procedure and Training Sessions
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Dec 2026to 31 Dec 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between ages of 22-70
- At least 1 year post SCI
- Confirmed SCI according to SCI clinician according to clinical history and the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) / American Spinal Injury Association (ASIA) criteria as documented in the American Spinal Injury Association Impairment Scale (AIS) on examination. Other disorders of gait will be excluded by history and a neurological examination.
- Persons with incomplete injury grades of ASIA C or D who can stand with support and who have some voluntary leg function and a maximum walking capacity of Walking Index for spinal cord injury - level II (WISCI-II) level 9 or less.
- Injury level T10 and above.
- Ability to stand with moderate body weight support for at least 5 minutes.
- Stable medical and physical condition.
- Able to commit to training/evaluation sessions over 6 months and for longer periodic follow-up.
Who cannot join
- Individuals with high-moderate to severe depression -Beck Depression Inventory II (BDI II) ≥ 25).
- Individuals with cognitive impairment indicated by a score of less than 24 on the Folstein Mini-Mental State Examination 2nd ed. (MMSE).
- Individuals with alcohol use disorder. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure harmful patterns of alcohol consumption over the past year. A cutoff score of 8 will be used to identify and exclude those with moderate to severe alcohol use behavior.
- Individuals with substance abuse. The Drug Abuse Screening Test (DAST-10) will be used to identify problematic substance abuse behavior over the past year. A cutoff score of 6 will be used to identify and exclude those with moderate to severe drug use behavior.
- The presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy as defined by past medical history and abnormal lab work at the investigator/surgeon's discretion.
- Individuals with a Berg Balance score < 21.
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- Individuals with a history of traumatic brain injury (TBI), seizures, severe autonomic dysreflexia, dysphagia or osteoporosis.
- History of prior intracranial surgery or known lesions.
- Individuals that require diathermy, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or serial brain MRIs.
- Individuals with non-MRI compatible metallic implants in their head or body, and with metallic implants and other implantable devices in the body that could be affected by DBS.
- Individuals with active implantable devices anywhere in the body (e.g., cardiac pacemaker, defibrillator, implanted medication pump).
- Individuals who are pregnant desire to become pregnant during the study.
- Individuals who are breastfeeding.
- Individuals with intractable orthostatic hypotension despite treatment.
- Individuals with a recent history of limb fracture, ligamentous injury, active pressure sores or unstable skin structures (e.g., skin grafts and chest tubes).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Miami Project to Cure Paralysis
Miami, Florida, 33136
Letitia Fisher, BLA, 3052433056, lfisher@miami.edu
David McMillan, PhD, 305-243-5569, dmcmillan1@med.miami.edu
- Recruiting
University of Miami School Of Medicine
Miami, Florida, 33136
Brian R Noga, PhD, 305-243-6155, BNoga@med.miami.edu
Letitia FISHER, BLA, 305-243-3056 ext. Noga, lfisher@miami.edu
About this study
This is a study about deep brain stimulation (DBS) as an investigational treatment for walking impairment following spinal cord injury (SCI). The purpose of this study is to assess the feasibility and inform on the safety, and efficacy of CnF DBS to improve gait in SCI patients with incomplete injury who cannot effectively walk overground
- Conditions
- Spinal Cord Injuries
- Being tested
- Deep Brain Stimulation (DBS), Deep Brain Stimulation (DBS) Device Implant Procedure, Training Sessions
- Keywords
- Spinal Cord Injury, deep brain stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS)Device
The DBS system delivers electrical current into deep areas of the brain. In this study, the electrical current will be delivered continuously during the study duration to an area of the brain called the cuneiform nucleus (CnF). Stimulation frequencies are anticipated to be between 20 and 50 Hertz. Participants may choose to continue stimulation following study termination. This area of the brain is associated with the body's ability to start a movement.
Deep Brain Stimulation (DBS) Device Implant ProcedureProcedure or surgery
Participants will undergo a one-time implantation of Cartesia DBS electrodes (bilateral) including the Vercise pulse generator in a single surgery (up to approximately 6 hours) to implant bilateral directional DBS leads in the cuneiform nucleus.
Training SessionsOther
Training sessions occurs 3 times/week at the study center to condition the subjects before DBS implantation and after DBS implantation. Each session may last up to 60 minutes. Training sessions include joint mobility (passive stretching), volitional neuromuscular activation (active hip mobility), task isolation (weight shifting), task integration (stepping), and activity rehearsal (walking).
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | Participants will be in the DBS study group for up to 34 weeks. Receives: Device: Deep Brain Stimulation (DBS); Procedure: Deep Brain Stimulation (DBS) Device Implant Procedure; Other: Training Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed measured by 10-meter walk test
The ten-meter walk test will be measured in meters/second.
Measured: baseline, up to 34 weeks
Change in distance measured by 6-min walk test
The 6-min walk test will be measured in meters
Measured: baseline, up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start31 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Miami Project to Cure Paralysis, Florida
- Responsible party
- Principal investigator, Brian Ronald Noga, University of Miami
- Investigators
- Brian R Noga, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109804
- Sponsor's protocol ID
- 20240334
- Other IDs
- GR025072
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hofer AS, Scheuber MI, Sartori AM, Skorup I, Gascho D, Colacicco G, Kiseleva A, Curt A, Stieglitz LH, Schwab ME. Stereotactic rodent-to-human approximation of the mesencephalic cuneiform nucleus to guide deep brain stimulation. Brain Stimul. 2026 Mar-Apr;19(2):103066. doi: 10.1016/j.brs.2026.103066. Epub 2026 Mar 3.
PubMed 41786287
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07109804
- Acronym / sponsor ID
- 20240334
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Miami Project to Cure Paralysis, Florida
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2025 (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.
This is a study about deep brain stimulation (DBS) as an investigational treatment for walking impairment following spinal cord injury (SCI). The purpose of this study is to assess the feasibility and inform on the safety, and efficacy of CnF DBS to improve gait in SCI patients with incomplete injury who cannot effectively walk overground
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | Device: Deep Brain Stimulation (DBS), Procedure: Deep Brain Stimulation (DBS) Device Implant Procedure, Other: Training SessionsParticipants will be in the DBS study group for up to 34 weeks. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects between ages of 22-70
- At least 1 year post SCI
- Confirmed SCI according to SCI clinician according to clinical history and the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) / American Spinal Injury Association (ASIA) criteria as documented in the American Spinal Injury Association Impairment Scale (AIS) on examination. Other disorders of gait will be excluded by history and a neurological examination.
- Persons with incomplete injury grades of ASIA C or D who can stand with support and who have some voluntary leg function and a maximum walking capacity of Walking Index for spinal cord injury - level II (WISCI-II) level 9 or less.
- Injury level T10 and above.
Key exclusion criteria (15 listed)
- Individuals with high-moderate to severe depression -Beck Depression Inventory II (BDI II) ≥ 25).
- Individuals with cognitive impairment indicated by a score of less than 24 on the Folstein Mini-Mental State Examination 2nd ed. (MMSE).
- Individuals with alcohol use disorder. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure harmful patterns of alcohol consumption over the past year. A cutoff score of 8 will be used to identify and exclude those with moderate to severe alcohol use behavior.
- Individuals with substance abuse. The Drug Abuse Screening Test (DAST-10) will be used to identify problematic substance abuse behavior over the past year. A cutoff score of 6 will be used to identify and exclude those with moderate to severe drug use behavior.
- The presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy as defined by past medical history and abnormal lab work at the investigator/surgeon's discretion.
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 |
|---|---|---|
| Deep Brain Stimulation (DBS)The DBS system delivers electrical current into deep areas of the brain. In this study, the electrical current will be delivered continuously during the study duration to an area of the brain called the cuneiform nucleus (CnF). Stimulation frequencies are anticipated to be between 20 and 50 Hertz. Participants may choose to continue stimulation following study termination. This area of the brain is associated with the body's ability to start a movement. | Device | Deep Brain Stimulation (DBS) |
| Deep Brain Stimulation (DBS) Device Implant ProcedureParticipants will undergo a one-time implantation of Cartesia DBS electrodes (bilateral) including the Vercise pulse generator in a single surgery (up to approximately 6 hours) to implant bilateral directional DBS leads in the cuneiform nucleus. | Procedure or surgery | Deep Brain Stimulation (DBS) |
| Training SessionsTraining sessions occurs 3 times/week at the study center to condition the subjects before DBS implantation and after DBS implantation. Each session may last up to 60 minutes. Training sessions include joint mobility (passive stretching), volitional neuromuscular activation (active hip mobility), task isolation (weight shifting), task integration (stepping), and activity rehearsal (walking). | Other | Deep Brain Stimulation (DBS) |
Primary outcome
Change in walking speed measured by 10-meter walk test
Time frame: baseline, up to 34 weeks
The ten-meter walk test will be measured in meters/second.
Change in distance measured by 6-min walk test
Time frame: baseline, up to 34 weeks
The 6-min walk test will be measured in meters
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 29 Oct 2026.
- Derived from this study: PubMed 41786287Hofer AS, Scheuber MI, Sartori AM, Skorup I, Gascho D, Colacicco G, Kiseleva A, Curt A, Stieglitz LH, Schwab ME. Stereotactic rodent-to-human approximation of the mesencephalic cuneiform nucleus to guide deep brain stimulation. Brain Stimul. 2026 Mar-Apr;19(2):103066. doi: 10.1016/j.brs.2026.103066. Epub 2026 Mar 3.
- 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.
Brian R Noga, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (DBS), Deep Brain Stimulation (DBS) Device Implant Procedure and Training Sessions in people with Spinal Cord Injuries, run by University of Miami at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Brian R Noga, Ph.D. (305-243-6155, BNoga@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed measured by 10-meter walk test (time frame: baseline, up to 34 weeks). The study lists 2 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 NCT07109804, 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 29 Oct 2026.