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

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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using robots for intense physical therapy can help tetraplegic patients regain hand and arm function after nerve transfer surgery. The therapy aims to retrain the brain to use new nerve connections effectively. Robot-assisted therapy has shown promise in improving upper limb function in patients with neurological impairments, including those with chronic stroke.

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.

What data supports the effectiveness of the treatment Nerve transfer surgery, Upper limb robotic training for Rehabilitation after Surgery for Spinal Cord Injury?

Research shows that nerve transfer surgery can help restore upper limb function in people with cervical spinal cord injuries, improving their ability to perform daily activities and enhancing their quality of life. This technique can restore multiple functions with one procedure, although it requires a long recovery time. ^{1 2 3 4 5}

Is nerve transfer surgery safe for humans?

Nerve transfer surgery is generally considered safe and well-tolerated, with early results showing it can improve function with less immobilization compared to other surgeries, although it may take longer to see significant improvements. ^{1 6 7 8 9}

How does the treatment for spinal cord injury using nerve transfer surgery and upper limb robotic training differ from other treatments?

Nerve transfer surgery is a novel treatment for spinal cord injury that involves connecting a functioning nerve to a muscle affected by the injury, allowing multiple functions to be restored without the need for long-term rehabilitation. This differs from traditional tendon transfer surgeries, which require immobilization and targeted therapy, and may not offer the same range of functional recovery. ^{1 2 3 5 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Use of Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Nerve transfer in patients with tetraplegia: improvement in hand function]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Expanding traditional tendon-based techniques with nerve transfers for the restoration of upper limb function in tetraplegia: a prospective case series. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Nerve Transfers in Tetraplegia. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Tendon Transfer Surgery for People With Tetraplegia: An Overview. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Nerve and Tendon Transfer Surgery in Cervical Spinal Cord Injury: Individualized Choices to Optimize Function. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Lower Motor Neuron Abnormality in Chronic Cervical Spinal Cord Injury: Implications for Nerve Transfer Surgery. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Iatrogenic Cervical Nerve Root Injury After Spine Surgery: How Nerve Surgeons Can Assist Spine Surgeons. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Improving hand function after spinal cord injury. [2022]