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| ID | Type | Description | Link |
|---|---|---|---|
| GR025072 | Other Grant/Funding Number | State of Florida |
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| Name | Class |
|---|---|
| The Miami Project to Cure Paralysis | OTHER |
| Florida | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | Participants will be in the DBS study group for up to 34 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in walking speed measured by 10-meter walk test | The ten-meter walk test will be measured in meters/second. | baseline, up to 34 weeks |
| Change in distance measured by 6-min walk test | The 6-min walk test will be measured in meters | baseline, up to 34 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian R Noga, Ph.D. | Contact | 305-243-6155 | BNoga@med.miami.edu | |
| Letitia Fisher, BLA | Contact | 305-243-3056 | lfisher@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian R Noga, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miami Project to Cure Paralysis | Recruiting | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41786287 | Derived | 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. |
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| Deep Brain Stimulation (DBS) Device Implant Procedure | Procedure | 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. |
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| Training Sessions | Other | 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). |
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| University of Miami School Of Medicine | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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