What side effects are associated with this type of intervention?

Lumbosacral Epidural Stimulation (ES) with Wearable Robot Suit (EAW) for spinal cord injury (SCI) can lead to several mild side effects. These may include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare. Additionally, the use of such devices requires specialized training and support, which can be a logistical challenge for many patients.

What prior FDA approvals exist?

The FDA has approved various treatments for spinal cord injury (SCI), but specific approvals for treatments similar to Lumbosacral Epidural Stimulation (ES) with Wearable Robot Suit (EAW) are not detailed in the provided context. However, the context mentions the use of epidural stimulation (ES) to help individuals with SCI regain motor control, which is a promising area of research. This technique involves stimulating the spinal cord to enhance motor function, often in combination with physical training or robotic assistance. While the context does not specify FDA-approved drugs or devices directly related to this method, it highlights the potential of neuromodulation and advanced rehabilitation technologies in improving outcomes for SCI patients.

What other types of research exist?

Promising alternatives to Lumbosacral Epidural Stimulation (ES) with Wearable Robot Suit (EAW) for SCI patients include: 1) Electromyogram-triggered Functional Electrical Stimulation (FES), which uses muscle activity signals to trigger stimulation and improve gait coordination. 2) Evoked Electromyographically Controlled Electrical Stimulation, which compensates for muscle time-variances to achieve stable neuroprosthetic muscle control. Both methods show potential for enhancing motor control and facilitating community ambulation.

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Device

Epidural Stimulation + Resistance Training for Spinal Cord Injury (REST-SCI Trial)

Phase 2 & 3

Recruiting

Led By Ashraf S Gorgey, PhD

Research Sponsored by United States Department of Defense

Eligibility Criteria Checklist

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

Must have

All participants will be between 18-60 years old, male or female, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam.

Participants' knee extensors must respond to standard surface NMES procedures to ensure intact neural circuitry below the level of SCI

Must not have

Pressure ulcer of grade 3 or more

Untreated or uncontrolled hypertension and severe orthostatic hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 6 months for 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for people with severe spinal cord injuries. It combines electrical stimulation, a robotic walking suit, and muscle-strengthening exercises to help them walk and improve muscle strength. Recent advancements have combined electrical stimulation with robotic exoskeletons to facilitate movement and improve motor recovery in individuals with spinal cord injuries. The goal is to make it easier for these individuals to move and improve their overall health.

Who is the study for?

This trial is for adults aged 18-60 with traumatic motor complete spinal cord injury (SCI) at T10 level or above. They must have intact neural circuitry below the SCI as confirmed by tests, and fit specific criteria like having certain muscle responses. People with severe bone density loss, unhealed fractures, major cardiovascular issues, untreated severe spasticity or pressure sores, among other exclusions, cannot participate.

What is being tested?

The study is testing whether using an 'ES Robot Suit' combined with resistance training can improve movement control in people who are paralyzed due to SCI. It compares those who use the suit with epidural stimulation alone to those who also do resistance training for better muscle quality and overall health.

What are the potential side effects?

Potential side effects may include discomfort from the device or stimulation, skin irritation where electrodes are placed, increased spasticity or muscle spasms during use of the equipment. There's also a risk of falls when using walking devices.

Eligibility Criteria

Inclusion Criteria

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

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I am 18-60 years old with a spinal cord injury above T10, confirmed by tests.

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My leg muscles respond to electrical stimulation after my spinal cord injury.

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I have a spinal injury classified as AIS A or B with motor issues below the injury.

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My spinal cord injury is severe, above T10, and confirmed by tests.

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I am between 18 and 60 years old.

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I have a spinal injury classified as AIS A or B, showing motor deficit below the injury level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe pressure ulcer.

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I have high blood pressure that isn't managed or severe dizziness when standing up.

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I do not have severe scoliosis or joint issues that prevent me from using an exoskeleton.

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I have a fracture in my arm or leg that hasn't healed.

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I do not have severe heart disease, unmanaged diabetes, high blood pressure, major skin sores, or a serious urinary infection.

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I have a neurological injury that affects my limbs or lower back, not caused by spinal cord injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 6 months for 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 6 months for 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 6 months for 12 months 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 10-meter over ground walking-speed

Change in EMG Pattern

Secondary study objectives

Change in Oxygen uptake

Changes in Systolic and Diastolic Blood Pressure

Changes in regional fat mass

Other study objectives

Changes in Bladder Filling and Emptying using Fluoroscopy and EMG

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

Group I: EAW+ES+RTExperimental Treatment3 Interventions

The exoskeletal assisted walking with epidural simulation and resistance training (EAW+ES+RT) group will undergo 6 months of supervised EAW +ES (3X per week) followed by additional 6 months of EAW+ES (3X per week) and progressive RT twice weekly (2X per week). In the EAW+ES+RT group, RT will be administered for 12 weeks using an open kinematic chain approach of applying surface NMES and ankle weights followed by 12 weeks twice weekly of gradually using the implanted ES to perform sit-to-stand approach (i.e. using their body weights to load the exercising muscles in a closed kinematic fashion).

Group II: EAW+ delayed-ES +no-RTExperimental Treatment3 Interventions

The control exoskeletal assisted walking with delayed epidural simulation and without resistance training (EAW+ delayed-ES +no-RT) group will enroll in 6 months of EAW without ES (3X per week) and then this will be followed by additional 6 months (3x per week) of EAW+ES (i.e., delayed entry approach) without conducting RT and will perform either passive movement of passive stretching (2X per week).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resistance Training

2019

Completed Phase 2

~1230

0 / 12Eligibility 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

Lumbosacral epidural stimulation (ES) combined with a wearable robot suit (EAW) is a promising treatment for spinal cord injury (SCI) that works by delivering electrical currents to the spinal cord to enhance motor control and facilitate movement. This stimulation helps to activate neural circuits below the site of injury, promoting muscle contractions and improving motor function. The wearable robot suit assists in movement, providing support and enabling repetitive training, which is crucial for neuroplasticity and motor recovery. These mechanisms are vital for SCI patients as they can lead to significant improvements in mobility, independence, and overall quality of life.