What is the mechanism of action of this treatment?

The most common treatments for spinal cord injury (SCI) include robot-assisted, intensive rehabilitation, which supports the return of hand and arm function and strengthens cortical representations of targeted muscles. This treatment works by providing repetitive, task-specific training that promotes neuroplasticity, the brain's ability to reorganize itself by forming new neural connections. This is crucial for SCI patients as it can lead to improved motor function and independence. Additionally, other treatments like constraint-induced movement therapy and functional electrical stimulation also aim to enhance neuroplasticity and muscle strength, further aiding in the recovery of motor skills and overall quality of life for SCI patients.

What side effects are associated with this type of intervention?

Common treatments for Spinal Cord Injury (SCI) such as physical therapy, occupational therapy, and robot-assisted intensive rehabilitation generally have minimal side effects. However, patients may experience muscle soreness, fatigue, and, in some cases, temporary increases in pain due to the physical exertion involved. Additionally, there is a risk of skin irritation or pressure sores from prolonged use of robotic devices or orthotic supports. It is important for patients to work closely with their healthcare providers to monitor and manage these potential side effects.

What prior FDA approvals exist?

There are currently no FDA-approved drugs specifically for the treatment of spinal cord injury that directly support the return of hand and arm function and strengthen cortical representations of targeted muscles. However, various rehabilitation techniques, including robot-assisted intensive rehabilitation, are being studied for their potential benefits in improving motor function in SCI patients. These therapies aim to enhance neuroplasticity and functional recovery through repetitive, task-specific training. While pharmacological treatments for SCI focus on managing symptoms and complications, the integration of advanced rehabilitation technologies represents a promising area of research.

What other types of research exist?

Promising novel alternatives to robot-assisted, intensive rehabilitation for spinal cord injury patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in enhancing motor function and cortical plasticity. 2) Transcranial Magnetic Stimulation (TMS), which can improve motor recovery and cortical reorganization. 3) Intensive task-specific training programs, which focus on repetitive, goal-directed activities to improve motor skills. 4) Virtual reality-based rehabilitation, which provides immersive environments to enhance motor learning and engagement. 5) Pharmacological agents like neurotrophic factors or drugs that promote neural repair and plasticity.

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Procedure

Rehabilitation after Surgery for Spinal Cord Injury

Phase 2

Waitlist Available

Research Sponsored by Burke Medical Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).

Demonstrate stability of motor examination for at least six months.

Timeline

Screening 3 days

Treatment 6 weeks

Follow Up 1 year post surgery, immediately post training, minus baseline before surgery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from TMS, surgical risks like infection or poor wound healing, possible pain during rehabilitation exercises, and fatigue associated with intensive physical therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My paralyzed muscles can still respond to nerve signals.

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

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

Timeline

Screening ~ 3 days2 visits

Treatment ~ 6 weeks22 visits

Follow Up ~ 1 year post surgery, immediately post training, minus baseline before surgery

Screening ~ 3 days

Treatment ~ 6 weeks

Follow Up ~1 year post surgery, immediately post training, minus baseline before surgery

This trial's timeline: 3 days for screening, 6 weeks for treatment, and 1 year post surgery, immediately post training, minus baseline before surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Box and Blocks test score

Secondary study objectives

Modified Ashworth Scale

Single pulse transcranial magnetic stimulation

Spinal Cord Independence Measure (SCIM III)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for spinal cord injury (SCI) include robot-assisted, intensive rehabilitation, which supports the return of hand and arm function and strengthens cortical representations of targeted muscles. This treatment works by providing repetitive, task-specific training that promotes neuroplasticity, the brain's ability to reorganize itself by forming new neural connections. This is crucial for SCI patients as it can lead to improved motor function and independence. Additionally, other treatments like constraint-induced movement therapy and functional electrical stimulation also aim to enhance neuroplasticity and muscle strength, further aiding in the recovery of motor skills and overall quality of life for SCI patients.

Motor Restoration and Spasticity Management after Stroke.