Intelligent Spine Interface, Clinical (ISI-C)
Key facts
- Who runs it
- Rhode Island Hospital
- Where
- Providence, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 3 people enrolled
- Started
- 1 Sept 2021
- Ended
- 30 Jun 2025
- Type of study
- Interventional
- Treatments tested
- Intelligent Spine Interface
- Record updated
- 14 August 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- • 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
Who cannot take part
- • 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
Where in United States
- Rhode Island HospitalProvidence, United StatesNo longer taking part
About the trial
What the trial wants to find out
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 spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs.
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This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface - Commercial, ISI-C) that will be implanted.
The group in the trial
- SCI PatientTreatment being tested
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
Treatment: Intelligent Spine Interface
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Early Feasibility Study to Evaluate ISI-C in SCI Patients
- Record updated
- 14 August 2026