Epidural Stimulation for Spinal Cord Injuries

Phase-Based Estimates
1
Effectiveness
2
Safety
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Epidural Stimulation - Device
Eligibility
18 - 65
All Sexes
Eligible conditions
Spinal Cord Injuries

Study Summary

Epidural Stimulation and Resistance Training After SCI

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Epidural Stimulation will improve 2 primary outcomes, 3 secondary outcomes, and 1 other outcome in patients with Spinal Cord Injuries. Measurement will happen over the course of Baseline to 12 months.

Baseline to 12 months
Change in 10-meter over ground walking-speed
Change in EMG Pattern
Changes in Bladder Filling and Emptying using Fluoroscopy and EMG
Changes in Systolic and Diastolic Blood Pressure
Changes in regional fat mass
Month 12
Change in Oxygen uptake

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
EAW+ delayed-ES +no-RT

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Epidural Stimulation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

EAW+ delayed-ES +no-RTThe 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).
EAW+ES+RTThe 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistance Training
2019
Completed Phase 2
~1290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and every 6 months for 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and every 6 months for 12 months for reporting.

Who is running the study

Principal Investigator
A. S. G.
Ashraf S. Gorgey, Director of SCI Research
Virginia Commonwealth University

Closest Location

Hunter Holmes McGuire VA Medical Center - Richmond, VA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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 (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI.
Participants will be evaluated for their level of impairment, level of function, and quality of life. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes spinal cord injuries?

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The most common injuries were high force trauma, penetrating injuries, and falls from heights. The cause of SCI is complicated by the fact that a different injury pattern occurs in each individual case, but for every individual case, a specific cause-related injury pattern for the injury has been suggested. What causes SCIs?

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What are common treatments for spinal cord injuries?

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The most common treatment for spinal cord injuries is hospitalization, often following an accident. Most patients recover, and physical therapy is not considered a treatment. There is no evidence to prove that orthotics help maintain posture. There is a lack of consensus about the use of casts and braces for post-acute spinal cord injuries. Androsterone was found to be beneficial in improving muscle strength and endurance. There is no evidence to support the use of surgery for spinal cord injuries and there have been no successful attempts to restore full movement after spinal cord injuries.

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How many people get spinal cord injuries a year in the United States?

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Each year, around 2,900 people are diagnosed with a cervical spinal cord injury and 5,100 people are diagnosed with a thoracic spinal cord injury. For those who recover, the chance of achieving full independence is about 50-60%. For those who do not, the chance is about 20-30%.

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What are the signs of spinal cord injuries?

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There are a wide variety of subtle neurologic signs of spinal cord injury. These signs are often difficult to detect with the nonneurologic clinician or, in most cases, in the acute phase of the injury. The clinical manifestations of spinal cord injury are very complex, in addition to multiple etiologies.

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Can spinal cord injuries be cured?

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Overall, most SCI patients and their families are able to deal with their injuries. However, some patients have severe emotional distress or depression. Depression is hard to treat and may be untreatable. We recommend that SCI patients be screened for depression with self-report inventories.

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What is spinal cord injuries?

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Spinal cord injuries (SCI) can cause a wide range of disabling conditions such as motor, sensory, urinary and bowel disturbances. The impact is profound on the person and on their families.\n

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Who should consider clinical trials for spinal cord injuries?

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A significant number of SCI patients are eligible for clinical trials. There is a potential to identify treatments for SCI. The cost and time of implementing such studies is high. At this early stage, it is unclear if such studies lead to a real improvement in care.

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What is the average age someone gets spinal cord injuries?

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Injuries occur during adolescence, particularly for males. Because more than one in 6 individuals over the age of 60 is affected by an SCI, the current rate has the potential to be one of the most important reasons why SCIs are becoming a growing health issue.

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Does spinal cord injuries run in families?

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This family study found that SCIs run in families. This is the first family-based study of SCI and highlights the importance of genetic predisposition in the aetiology of SCI.

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What are the latest developments in exoskeletal assisted walking for therapeutic use?

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The findings from this study demonstrated that patients with a history of spinal cord injury can achieve a dynamic walking pattern using the exoskeletal aid. This enables patients to participate in conventional physical therapy, thereby increasing their participation and function in rehabilitation.

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Has exoskeletal assisted walking proven to be more effective than a placebo?

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Participation of a patient with incomplete cervical spondylotic myelopathy in a 6-month exoskeleton-assisted functional training program resulted in a greater gain in walking ability, functional independence, and patient satisfaction than with a placebo-controlled group. The study suggests that a rehabilitation program for patients with incomplete cervical spondylotic myelopathy can lead to clinically useful functional gains.

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Is exoskeletal assisted walking safe for people?

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Walking with exoskeletal assistive devices can be tolerated by at least 79% of people with SCI over 3 months post injury. Results from a recent clinical trial does not support the current debate about the safety of exoskeleton assisted walking vs. conventional gait training for people with SCI. Further research, however, is warranted to establish the effects of long-term use of this technology on walking speed and quality of life for people with SCI.

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