Rehabilitation after Surgery for Spinal Cord Injury

Overseen By Liz Magier, MPA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Burke Medical Research Institute

Disqualifiers: Seizures, Pacemaker, Head trauma, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of rehabilitation in helping people regain hand and arm function after spinal cord surgery. It examines whether robots in therapy can enhance movement and brain activity related to these muscles. Participants will undergo nerve transfer surgery and engage in upper limb robotic training at different times to determine the most effective approach. Ideal candidates for this trial are those with tetraplegia (paralysis in all four limbs) who have some hand movement issues and have been stable for at least six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in rehabilitation therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nerve transfer surgery can be a safe option for people with spinal cord injuries. It improves motor function, making muscle movement easier. Although recovery takes time and full movement might not return, the surgery can significantly enhance quality of life.

Robotic training for the upper limb has also proven safe. It enhances movement abilities without causing harm. Many patients have improved their motor skills after this therapy.

Both treatments have strong safety records, making them promising options for those considering clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for spinal cord injury because they combine nerve transfer surgery with innovative upper limb robotic training. Unlike traditional rehabilitation methods that focus solely on physical therapy, this approach aims to enhance nerve regeneration and improve motor function by directly rewiring nerve pathways. The use of robotic training one year post-surgery is particularly groundbreaking, as it provides precise, repetitive movements that can enhance recovery. This dual approach could potentially offer more significant improvements in upper limb function compared to standard physical therapy alone.

What evidence suggests that this trial's treatments could be effective for improving hand and arm function in tetraplegic patients?

Research shows that nerve transfer surgery can restore movement in muscles paralyzed by spinal cord injuries. Studies have found that patients undergoing this surgery continue to regain motor function. In this trial, participants will receive nerve transfer surgery followed by upper limb robotic training. Evidence suggests that robotic training for the upper limbs improves movement in individuals with long-term spinal cord injuries. This training has boosted the function of the arms and hands. Together, these treatments offer hope for enhancing hand and arm function in patients with tetraplegia. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with tetraplegia due to spinal cord injury who have stable motor function and can consent to the study. They must have specific muscle strength, intact nerve connections as confirmed by tests, and a caregiver for post-surgery therapy. Those with seizure history, metal implants affecting brain stimulation, or unsuitable for surgery are excluded.

Inclusion Criteria

My muscles controlled by the nerves for the planned transfer are strong and well-functioning.

I have someone at home to help me with physical therapy after surgery.

I have someone at home to help me with physical therapy after surgery.

Exclusion Criteria

I have had a head injury or struggle with thinking or memory.

I cannot have surgery to repair nerve damage.

I have a history of seizures or metal implants in my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nerve Transfer Surgery

Participants undergo nerve transfer surgery to restore function after spinal cord injury

1 day

Recovery

Participants recover from surgery and prepare for rehabilitation

1 year

Robotic Training

Participants receive six weeks of upper limb robotic training to improve hand and arm function

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nerve transfer surgery
• Upper limb robotic training

Trial Overview The study examines how robot-assisted rehabilitation after nerve transfer surgery affects hand function and brain activity in patients with spinal cord injuries. The effectiveness will be measured using clinical assessments of hand/arm function and Transcranial Magnetic Stimulation (TMS) mapping.

How Is the Trial Designed?

Group I: Nerve transfer + robotic training Experimental Treatment 2 Interventions

Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY.

Group II: Nerve transfer + delayed robotic training Active Control 2 Interventions

Participants will receive nerve transfer surgery at Massachusetts General Hospital in Boston, MA. One year + six weeks after the surgery, participants will receive six weeks of upper limb robotic training at the Burke Neurological Institute in White Plains, NY.

Who Is Running the Clinical Trial?

Burke Medical Research Institute

Lead Sponsor

Trials

24

Recruited

1,500+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5023083/

Review of Upper Extremity Nerve Transfer in Cervical Spinal ... This review documents the current status of nerve transfer surgery for upper limb reanimation in tetraplegia and summarizes the functional results in 59 cases.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04023591

NCT04023591 | Nerve Transfer After Spinal Cord Injury- ... Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2799013

Upper Limb Nerve Transfer Surgery in Patients With ... Nerve transfers in subacute and chronic spinal cord injury resulted in comparable outcomes, and continual motor recovery was observed after ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X25000553

Evaluating motor unit properties after nerve transfer surgery Nerve transfer surgery (NTS) shows promise in restoring movement to muscles paralyzed by spinal cord (SCI) and peripheral nerve injury (PNI) ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29551672/

The Use of Nerve Transfers to Restore Upper Extremity ... Nerve transfer surgery to restore upper extremity function in cervical spinal cord injury (SCI) is novel and may transform treatment.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666379124006128

Long-term clinical and safety outcomes from a single-site ... Patient 010 improved to one level of sensory and motor improvement at six months and then remained stable throughout the duration of the study.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10696649/

Assessment, patient selection, and rehabilitation of nerve ... Compared to conventional nerve grafting, nerve transfers offer opportunities to reinnervate muscles affected by cervical spinal cord injury and ...

8. read.houstonmethodist.org read.houstonmethodist.org/bringing-back-hand-function

Bringing Back Hand Function in People with Complete ... The recovery from nerve transfers is slow and won't restore the lost movement completely, but it will certainly improve quality of life vastly.

9. community.the-hospitalist.org community.the-hospitalist.org/content/nerve-transfer-improves-function-after-spinal-cord-injury

Nerve transfer improves function after spinal cord injury Early nerve transfer surgery is safe and can provide significant functional improvement to patients with cervical spinal cord injury and tetraplegia, according ...