What side effects are associated with this type of intervention?

Robotic Gait Training (RGT) is generally well-tolerated, but some patients may experience skin irritation, muscle soreness, or fatigue due to the physical exertion involved. Transcranial Magnetic Stimulation (TMS) is also considered safe, with the most common side effects being mild headaches, scalp discomfort at the stimulation site, and, rarely, seizures. Both treatments are non-invasive and have a low risk of serious adverse effects, making them promising options for enhancing neuroplasticity and improving functional outcomes in spinal cord injury patients.

What prior FDA approvals exist?

The FDA has approved various treatments for Spinal Cord Injury (SCI) that focus on improving mobility and enhancing neuroplasticity. Robotic Gait Training (RGT) devices, such as exoskeletons, have been approved to assist and improve walking ability in individuals with SCI. These devices help patients regain mobility by providing mechanical support and facilitating repetitive walking movements. Additionally, Transcranial Magnetic Stimulation (TMS) has been explored as a method to stimulate nerve cells in the brain, promoting neuroplasticity and potentially aiding in the recovery of motor functions. While TMS is not yet widely approved specifically for SCI, it shows promise in clinical trials and is approved for other neurological conditions, indicating its potential future application in SCI treatment.

What other types of research exist?

Promising novel alternatives for SCI patients include Transcranial Direct Current Stimulation (tDCS), which uses low electrical currents to stimulate brain activity and enhance neuroplasticity, and Percutaneous Electrical Nerve Stimulation (PENS), which involves inserting needles near nerves to deliver electrical stimulation and improve motor function. Both have shown potential in recent studies for improving outcomes in SCI patients.

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Robotic Gait Training

Robotic Gait Training for Spinal Cord Injury (DOOR SCI Trial)

N/A

Recruiting

Led By Chad Swank, PhD, PT, NCS

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

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

Must have

All types of motor incomplete SCI (traumatic and non-traumatic)

Must not have

Concurrent moderate to severe traumatic brain injury (TBI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses robotic devices and magnetic stimulation to help people with partial spinal cord injuries recover better. It focuses on rehabilitation to maximize recovery by practicing walking and stimulating the brain. Robotic devices and magnetic stimulation are increasingly used in neurorehabilitation to facilitate repetitive motor training and enhance recovery in individuals with spinal cord injuries.

Who is the study for?

This trial is for individuals with motor incomplete spinal cord injuries, in the acute or subacute recovery phase. Participants must be medically stable and receiving care at Baylor Scott & White Institute for Rehabilitation. They should fit within the Ekso robotic exoskeleton's size limits and manage bladder/bowel continence. Exclusions include severe TBI, degenerative conditions, cognitive impairments, pregnancy, or living over 90 miles from the institute.

What is being tested?

The DOOR SCI study is testing how different amounts of robotic gait training (RGT) combined with transcranial magnetic stimulation (TMS) affect functional outcomes and brain changes after a spinal cord injury. This happens during inpatient rehab and continues into early outpatient care.

What are the potential side effects?

Potential side effects may include discomfort or skin irritation from wearing the robotic exoskeleton, fatigue due to exercise during gait training sessions, mild headaches or scalp sensations from TMS, but individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have an incomplete spinal cord injury that affects my movement.

Exclusion Criteria

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

Select...

I have a moderate to severe brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 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 Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline

Secondary study objectives

Change in 10-Meter Walk Test (10MWT)

Change in Fatigue Severity Scale (FSS)

Change in Life Satisfaction Questionnaire (LISAT)

+6 more

Other study objectives

Rate of adverse events

Rate of treatment completion

Self-reported tolerance of treatment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Moderate FrequencyExperimental Treatment1 Intervention

Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks

Group II: Low FrequencyExperimental Treatment1 Intervention

Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks

Group III: High FrequencyExperimental Treatment1 Intervention

Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks

Group IV: Control GroupActive Control1 Intervention

Subjects will receive usual care gait training without robotic gait training

0 / 2Eligibility 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

Robotic Gait Training (RGT) assists and improves walking ability in Spinal Cord Injury (SCI) patients by using robotic devices to facilitate repetitive practice of walking movements, promoting motor learning and muscle strength. Transcranial Magnetic Stimulation (TMS) stimulates nerve cells in the brain to enhance neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. These treatments are significant for SCI patients as they can potentially restore some motor functions and improve overall mobility, thereby enhancing the quality of life.

Restoring walking after spinal cord injury.