Status:
ACTIVE_NOT_RECRUITING
Intelligent Spine Interface, Clinical (ISI-C)
Lead Sponsor:
Rhode Island Hospital
Collaborating Sponsors:
US Department of Veterans Affairs
Brown University
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the...
Detailed Description
Intel Corporation, Nuvectra 18. US FDA Regulated: Yes 19. US FDA Regulated Drug: No 20. US FDA Regulated Device: Yes 21. US FDA Investigational New Device (IND)/Investigational Device Exemption (IDE):...
Eligibility Criteria
Inclusion
- • 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))
- Focal area of SCI due to trauma
- SCI date of injury \> 1 year prior to enrollment
- Completed prior SCI rehabilitation program
- Ability to use both upper extremities to ambulate with a wheelchair or crutches
- Distance between the conus medullaris and site of injury must be \> 4 cm
- The ability to participate in intensive physical therapy and research \> 4 hours per day for 2 weeks
- Must provide informed consent prior to study participation
Exclusion
- • Presence of co-existing lower extremity neuropathy or disorders of the cauda equina
- Presence of non-traumatic spinal cord pathology
- Significant cognitive impairment or decreased level of consciousness
- Presence of an intrathecal baclofen or morphine pump
- Presence of a cardiac defibrillator or pacemaker
- Presence of a deep brain stimulator device
- Patient who has any contraindication to having a MRI performed
- Severe or disabling joint contractures in the lower extremities
- Presence of hematologic disorder or medication related coagulopathy that would preclude surgery
- Lower extremity congenital or acquired deformities
- Women who are pregnant or who are unwilling to use contraception during the study period
- Body mass index \> 30
- Cardiopulmonary comorbidities that preclude participation in intensive physical therapy
- Known or suspected patient non-compliance during the study period and at follow up
- Patient life expectancy \< 12 months
- Presence of patient comorbidities or spinal anatomy that would preclude participation in the study per investigators' recommendation
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04302259
Start Date
September 1 2021
End Date
June 30 2025
Last Update
March 10 2025
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903