Rehabilitation after Surgery for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Burke Medical Research Institute

No Placebo Group

Prior Safety Data

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.

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 spinal cord injury is classified as A, B, C, or D on the ASIA scale.

Your motor abilities have not changed for at least six months.

My paralyzed muscles can still respond to nerve signals.

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.

Ability to give informed consent and understand the tasks involved.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Nerve transfer + robotic trainingExperimental Treatment2 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 trainingActive Control2 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.