Spinal Cord InjuryISI-CNCT04302259
Intelligent Spine Interface, Clinical (ISI-C)
A study testing Intelligent Spine Interface in people with Spinal Cord Injury, run by Rhode Island Hospital at 1 site in United States.
Trial 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 spinal cord of SCI patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Intelligent Spine Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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 join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: An Early Feasibility Study to Evaluate ISI-C in SCI Patients
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.
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.
Read 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): Yes 22. Human Subjects Protection Review: Pending Review 23. Data Monitoring Committee: Yes 24. FDA Regulated Intervention: Yes
- 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 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.
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) that will be implanted.
- Detailed Description:
The investigators propose to build an Intelligent Spine Interface (ISI) that will interpret neural information from above a spinal cord injury and transfer that information, via a state-of-the-art artificial neural network-based computer interpreter, to sites below the site of injury and restore control of the lower limbs.
At present, activity-based therapies (physical rehabilitation) are only medical practices that can be used to enhance recovery after spinal cord injury. However, most affected patients, who fail to produce active movements voluntarily, experience minimal benefits from such therapies.
This study is being done to develop a new treatment modality 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.
The device being used in this study is termed Intelligent Spine Interface. This device consists of: (1) surgically implanted electrode arrays placed above and below site of spinal cord injury. These arrays are connected to other device components outside the body (like "Ripple System") using specialized wires. (2) "Ripple System" collects readings from implanted electrode arrays. Together, these components are used to stimulate the spinal cord and sense any resulting nervous system signals. (3) Personal computer uses specialized software to interpret the nervous system activity.
The use of the ISI-C device in this study is considered investigational. This means the device has not yet been approved by the FDA.
The entire study should take about 7-8 months to complete.
Study Phases and Procedures:
- Screening Phase: Subject identification, consent process, eligibility review, preliminary assessments (imaging studies such as x-rays, blood work, physical/neurological exam, medical history, medication review, pregnancy test, electrocardiogram to assess heart health)
- Pre-rehabilitation Phase: baseline review of SCI related standardized outcome measures to understand if the device/treatment is producing the desired effect on the participant physical function (e.g. gait, balance, ability to walk, muscle tone/spasm, bowel function).
- Surgery: Pre-surgery testing, anesthesia administration, lead placement above and below the site of injury, wound closure and observation
- Inpatient Rehabilitation Phase: daily physical rehabilitation sessions in specialized gaits lab, neurostimulation protocol (small electrical pulses will be delivered to the implanted electrode array and any spinal cord activity will be recorded), follow-up SCI-related outcome measures review
- Surgery: same as above - surgically implanted leads will be removed
- Follow up phase: Follow-up physical and neurological exams to assess if there is a change in function since baseline
- Conditions
- Spinal Cord Injury
- Being tested
- Intelligent Spine Interface
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Spine InterfaceDevice
Also called spinal neuromodulation therapy, spinal cord stimulation device, epidural electrical stimulation system
ISI-C is a bi-directional, two anatomical location Epidural Electrical Stimulation (EES) system to bridge the lesion core in patients with chronic complete and incomplete spinal cord injury (SCI). This "Intelligent Spine Interface", or ISI will interpret recorded neural information from above a spinal cord lesion and transfer that information, via deep neural network-based interpreters (i.e. models), to stimulation sites (electrodes) below the lesion with the aim of restoring volitional control of the lower limb.
| Study group | Role | What they receive |
|---|---|---|
| SCI Patient | Experimental | 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 Receives: Device: Intelligent Spine Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety issues
Evaluate safety issues associated with the implantation and use of ISI technology i.e. frequency of device related adverse events
Measured: 8 months
Secondary outcomes (9)
Neurological Outcome Measures
Assess neurological outcomes before, during, and after ISI implantation in SCI patients via ISNCSCI evaluation
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via 6 Minute Walk Test
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via 10 minute timed walk test
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via Time Up and Go test
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via Spinal cord Injury Functional Ambulation Inventory
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via Spinal Cord Injury Quality of Life (SCI-QOL): Ambulation Short Form
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via SCI Functional Ambulatory Inventory (FAI)
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via Berg Balance Scale
Measured: 8 months
Functional Outcome Measures
Assess functional outcomes before, during, and after ISI implantation in SCI patients via Mini-Best test
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Sep 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Brown University, Intel Corporation
- Responsible party
- Sponsor
- Investigators
- David Borton, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302259
- Sponsor's protocol ID
- 001020
- Acronym
- ISI-C
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2020
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study to Evaluate ISI-C in SCI Patients
- ClinicalTrials.gov ID
- NCT04302259
- Acronym / sponsor ID
- ISI-C / 001020
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Brown University, Intel Corporation
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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): Yes 22. Human Subjects Protection Review: Pending Review 23. Data Monitoring Committee: Yes 24. FDA Regulated Intervention: Yes
- 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 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.
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) that will be implanted.
- Detailed Description:
The investigators propose to build an Intelligent Spine Interface (ISI) that will interpret neural information from above a spinal cord injury and transfer that information, via a state-of-the-art artificial neural network-based computer interpreter, to sites below the site of injury and restore control of the lower limbs.
At present, activity-based therapies (physical rehabilitation) are only medical practices that can be used to enhance recovery after spinal cord injury. However, most affected patients, who fail to produce active movements voluntarily, experience minimal benefits from such therapies.
This study is being done to develop a new treatment modality 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.
The device being used in this study is termed Intelligent Spine Interface. This device consists of: (1) surgically implanted electrode arrays placed above and below site of spinal cord injury. These arrays are connected to other device components outside the body (like "Ripple System") using specialized wires. (2) "Ripple System" collects readings from implanted electrode arrays. Together, these components are used to stimulate the spinal cord and sense any resulting nervous system signals. (3) Personal computer uses specialized software to interpret the nervous system activity.
The use of the ISI-C device in this study is considered investigational. This means the device has not yet been approved by the FDA.
The entire study should take about 7-8 months to complete.
Study Phases and Procedures:
- Screening Phase: Subject identification, consent process, eligibility review, preliminary assessments (imaging studies such as x-rays, blood work, physical/neurological exam, medical history, medication review, pregnancy test, electrocardiogram to assess heart health)
- Pre-rehabilitation Phase: baseline review of SCI related standardized outcome measures to understand if the device/treatment is producing the desired effect on the participant physical function (e.g. gait, balance, ability to walk, muscle tone/spasm, bowel function).
- Surgery: Pre-surgery testing, anesthesia administration, lead placement above and below the site of injury, wound closure and observation
- Inpatient Rehabilitation Phase: daily physical rehabilitation sessions in specialized gaits lab, neurostimulation protocol (small electrical pulses will be delivered to the implanted electrode array and any spinal cord activity will be recorded), follow-up SCI-related outcome measures review
- Surgery: same as above - surgically implanted leads will be removed
- Follow up phase: Follow-up physical and neurological exams to assess if there is a change in function since baseline
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI Patient | Experimental | Device: Intelligent Spine InterfaceComplete or Incomplete Spinal Cord Injury (SCI) patients with Asia Impairment Score (AIS) of A or B between the levels of C7/T1 and T10 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Adults (men or women) between the ages of 18 and 65 years old
Key exclusion criteria (16 listed)
- • Presence of co-existing lower extremity neuropathy or disorders of the cauda equina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Spine InterfaceAlso: spinal neuromodulation therapy, spinal cord stimulation device, epidural electrical stimulation systemISI-C is a bi-directional, two anatomical location Epidural Electrical Stimulation (EES) system to bridge the lesion core in patients with chronic complete and incomplete spinal cord injury (SCI). This "Intelligent Spine Interface", or ISI will interpret recorded neural information from above a spinal cord lesion and transfer that information, via deep neural network-based interpreters (i.e. models), to stimulation sites (electrodes) below the lesion with the aim of restoring volitional control of the lower limb. | Device | SCI Patient |
Primary outcome
Evaluate safety issues
Time frame: 8 months
Evaluate safety issues associated with the implantation and use of ISI technology i.e. frequency of device related adverse events
9 secondary outcomes
Neurological Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Functional Outcome Measures
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Borton, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Spine Interface in people with Spinal Cord Injury, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety issues (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.