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CompletedNo phase

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