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Neuromodulation Device
Neuromodulation Techniques for Spinal Cord Injury
Phase 2
Recruiting
Led By Ashraf Gorgey, PhD PT
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants will be between 18-70 years old, male, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial is testing if a robotic suit can help people with spinal cord injuries walk, which could help with other health problems associated with the injury.
Who is the study for?
This trial is for males aged 18-70 with traumatic motor complete spinal cord injury (SCI) at T10 level or above. They must have specific motor deficits, functional limb range of motion, and pass safety assessments like the Modified Ashworth Scale. Excluded are those with other neurological injuries, unhealed fractures, severe scoliosis or contractures that prevent exoskeleton use, certain implanted devices, low bone density scores, untreated severe conditions such as hypertension or diabetes.Check my eligibility
What is being tested?
The study tests two rehabilitation techniques for SCI: one combines an exoskeleton suit with spinal cord epidural stimulation (EAW+SCES), and the other pairs the suit with transspinal stimulation (EAW+TS). The goal is to improve standing and walking abilities while reducing health issues related to SCI.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the exoskeleton or during stimulation procedures. There might also be risks of skin irritation where electrodes are placed for stimulation and muscle fatigue due to physical therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18-70 with a severe spinal cord injury above T10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10-meter walking speed (m/sec)
Muscles electromyography (EMG) activity (micro-volts)
Secondary outcome measures
Fasting lipid profile (mg/dl)
Fat mass and fat-free mass (kg)
Oxygen Uptake (ml/min)
Other outcome measures
Urinary Bladder
Trial Design
2Treatment groups
Experimental Treatment
Group I: EAW+TSExperimental Treatment1 Intervention
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
Group II: EAW+SCESExperimental Treatment1 Intervention
Three months of exoskeleton training followed by 6 months of epidural stimulation.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,621 Previous Clinical Trials
3,323,491 Total Patients Enrolled
Virginia Commonwealth UniversityOTHER
700 Previous Clinical Trials
22,886,810 Total Patients Enrolled
Ashraf Gorgey, PhD PTPrincipal InvestigatorHunter Holmes McGuire VA Medical Center, Richmond, VA
2 Previous Clinical Trials
38 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker or defibrillator implanted in your body.I have a severe pressure ulcer on my trunk, pelvis, or legs.You cannot use the device for any reason.I am a man aged 18-70 with a severe spinal cord injury above T10.I have a fracture in my arm or leg that hasn't healed.I have high blood pressure or severe dizziness when standing.I am on blood thinners that I cannot stop for medical reasons.My doctor says my severe muscle stiffness cannot be treated.You will have a test to check your spinal cord function, and only those with severe motor deficits below the level of the injury will be included.Your bone density scan shows that your bones are weaker than normal.I do not have severe heart disease, unmanaged diabetes, high blood pressure, major skin sores, or a serious urinary infection.I have a nerve injury that is not a spinal cord injury but affects my limbs or lower back.I have severe scoliosis or joint issues that prevent me from using an exoskeleton.My muscle stiffness has been checked for safety before starting rehab.My arms and legs have been checked for movement, strength, tightness, and skin health.I have severe muscle stiffness or limited movement.
Research Study Groups:
This trial has the following groups:- Group 1: EAW+TS
- Group 2: EAW+SCES
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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