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Intelligent Spine Interface for Spinal Cord Injury (ISI-C Trial)
N/A
Recruiting
Led By David Borton, PhD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (men or women) between the ages of 18 and 65 years old
Complete or Incomplete SCI with AIS grade of A or B between the levels of C7/T1 and T10 (level and degree of injury based on the international standards for neurological classification of SCI (ISNCSCI))
Must not have
Lower extremity congenital or acquired deformities
Presence of co-existing lower extremity neuropathy or disorders of the cauda equina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device called Intelligent Spine Interface (ISI-C) for spinal cord injury patients. The device reads nerve signals from above the injury and sends them to the lower spine to help control leg movements. It aims to help patients who do not benefit from current rehabilitation methods.
Who is the study for?
This trial is for adults aged 18-65 with spinal cord injury (SCI) between C7/T1 and T10, who are at least one year post-injury. Participants must have completed SCI rehab, be able to use their upper limbs for mobility, and commit to intensive therapy. Exclusions include pregnancy, BMI >30, co-existing neuropathies or disorders, contraindications to MRI or surgery, severe joint contractures or deformities in lower extremities.
What is being tested?
The study tests a new device called Intelligent Spine Interface (ISI-C), designed to help SCI patients regain lower limb function by understanding nervous system signals within the spinal cord. It involves imaging studies like X-rays, surgical implantation of ISI-C, body function assessments (balance/movement/gait), and physical rehabilitation.
What are the potential side effects?
Potential side effects may include discomfort from imaging procedures like X-rays; risks associated with surgery such as infection or bleeding; possible adverse reactions to the implanted device including inflammation or rejection; and fatigue from intensive physical therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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My spinal cord injury is between my neck and waist and is classified as severe or moderate.
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I have a spinal cord injury from an accident.
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I have completed a spinal cord injury rehab program.
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I can use my arms to move around with a wheelchair or crutches.
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I can do intensive physical therapy and research for more than 4 hours daily for 2 weeks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a birth defect or injury affecting my legs.
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I have nerve damage in my legs or lower back issues.
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I have a blood disorder or take medication that makes surgery unsafe.
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I have severe joint stiffness in my legs that limits movement.
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I have a spinal cord condition not caused by injury.
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I have significant memory or awareness issues.
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I have heart or lung conditions that prevent me from doing intense physical therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate safety issues
Secondary study objectives
Functional Outcome Measures
Neurological Outcome Measures
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SCI PatientExperimental Treatment1 Intervention
Complete or Incomplete Spinal Cord Injury (SCI) patients with Asia Impairment Score (AIS) of A or B between the levels of C7/T1 and T10
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
265 Previous Clinical Trials
68,825 Total Patients Enrolled
US Department of Veterans AffairsFED
875 Previous Clinical Trials
498,418 Total Patients Enrolled
Brown UniversityOTHER
466 Previous Clinical Trials
699,077 Total Patients Enrolled
Intel CorporationIndustry Sponsor
9 Previous Clinical Trials
28,778 Total Patients Enrolled
NuvectraIndustry Sponsor
2 Previous Clinical Trials
111 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
746 Previous Clinical Trials
857,986 Total Patients Enrolled
David Borton, PhDPrincipal InvestigatorBrown University