Deep Brain Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Brian R Noga, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Depression, Cognitive impairment, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 34 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called deep brain stimulation (DBS) to determine if it can improve walking in people with spinal cord injuries. It targets individuals who have some leg movement but cannot walk effectively without assistance. Participants should have had their spinal cord injury for at least a year and be able to stand with some support for five minutes. The study aims to assess the safety and effectiveness of DBS, specifically targeting the Cuneiform Nucleus (CnF), in enhancing walking ability. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could improve mobility for many with spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this deep brain stimulation is safe for spinal cord injury patients?

Research suggests that deep brain stimulation (DBS) targeting the cuneiform nucleus (CnF) could help improve walking difficulties after a spinal cord injury. In studies with rats, CnF-DBS enhanced movement, even with severe and incomplete spinal injuries. However, these results come from animal studies, and more research is needed to determine its effectiveness in humans.

This treatment is currently in the "Not Applicable" phase, meaning researchers are actively studying its safety in humans. This phase often involves testing how well people tolerate the treatment. While specific data on side effects for this use in humans is not yet available, DBS has been studied for other conditions, suggesting it might be safe. However, each study and condition differ, and ongoing research will help clarify its safety for people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Deep Brain Stimulation (DBS) for spinal cord injury is unique because it targets the brain directly to help restore function, unlike most treatments that focus on the spinal cord itself or rehabilitation therapies. Researchers are excited about this approach because DBS specifically stimulates the Cuneiform Nucleus (CnF), a part of the brain involved in movement control, which could potentially improve motor function more effectively. This method represents a novel mechanism of action that could provide benefits beyond what traditional therapies like physical rehabilitation and medication alone can offer.

What evidence suggests that Cuneiform Nucleus Deep Brain Stimulation is effective for walking impairment following spinal cord injury?

Research has shown that deep brain stimulation (DBS) of the cuneiform nucleus, a small area in the brain, can improve walking in people with spinal cord injuries. Animal studies, such as those conducted with rats, have demonstrated promising results. When researchers stimulated this brain region, rats with partial spinal cord injuries showed better movement and recovery. This indicates that DBS might strengthen weak signals from the brain to the legs, enhancing walking ability. Although information on humans remains limited, current findings suggest that DBS could benefit walking issues after spinal cord injuries. Participants in this trial will join the DBS study group for up to 34 weeks to further explore these potential benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Brian R Noga, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with incomplete spinal cord injuries who struggle to walk. Participants should be stable post-injury and have some ability to move their legs, but not enough to walk effectively on their own.

Inclusion Criteria

My health condition is stable.

I can stand with support, have some leg movement, and my walking ability is rated 8 or less on the WISCI-II scale.

My spinal cord injury is above the T10 level.

Exclusion Criteria

Individuals with cognitive impairment indicated by a score of less than 24 on the Folstein Mini-Mental State Examination 2nd ed. (MMSE)

I have had brain surgery or have known brain lesions.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deep brain stimulation (DBS) for gait facilitation

34 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cuneiform Nucleus (CnF) Deep Brain Stimulation

Trial Overview

The study tests if deep brain stimulation (DBS) in the Cuneiform Nucleus (CnF) can help improve walking abilities in people with spinal cord injuries. It involves implanting a DBS device and participating in training sessions to assess feasibility, safety, and effectiveness.

How Is the Trial Designed?

Group I: Deep Brain Stimulation (DBS) Experimental Treatment 3 Interventions

Participants will be in the DBS study group for up to 34 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Florida

Collaborator

Trials

10

Recruited

1,100+

The Miami Project to Cure Paralysis

Collaborator

Trials

6

Recruited

40+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07109804

Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait ...

Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury ... DBS to improve gait in SCI patients with incomplete injury ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11002271/

Electrical stimulation of the cuneiform nucleus enhances the ...

We analyzed whether CnF-DBS can be used to support medium-intensity locomotor training and long-term recovery in rats with large but incomplete spinal cord ...

3.

scitrials.org

scitrials.org/trial/NCT07109804

Spinal Cord Injury - NCT07109804

This trial aims to assess the feasibility of DBS to improve walking in those with incomplete injury who cannot effectively walk overground. Who can take part?

4.

ejnpn.springeropen.com

ejnpn.springeropen.com/articles/10.1186/s41983-025-00996-z

Efficacy of deep brain stimulation in locomotor function ...

Stimulation of the cuneiform nucleus enables training and boosts recovery after spinal cord injury. Brain. 2022;145(10):3681–97. Article ...

5.

academic.oup.com

academic.oup.com/brain/article/145/10/3681/6587425

Stimulation of the cuneiform nucleus enables training and ...

We show that deep brain stimulation of the cuneiform nucleus enhances the weak remaining motor drive in highly paraparetic rats with severe, incomplete spinal ...

6.

academic.oup.com

academic.oup.com/brain/article-pdf/145/10/3681/46598540/awac184.pdf

Stimulation of the cuneiform nucleus enables training and ...

We show that deep brain stimulation of the cuneiform nucleus enhances the weak remaining motor drive in highly paraparetic rats with severe, incomplete spinal ...

7.

trialx.com

trialx.com/clinical-trials/listings/325383/cuneiform-nucleus-cnf-deep-brain-stimulation-for-gait-facilitation-following-spinal-cord-injury/

Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait ...

Overview. This is a study about deep brain stimulation (DBS) as an investigational treatment for walking impairment following spinal cord ...