Intelligent Spine Interface for Spinal Cord Injury

(ISI-C Trial)

Overseen by David Borton, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rhode Island Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an intrathecal baclofen or morphine pump, you cannot participate in the trial.

What data supports the effectiveness of the treatment Intelligent Spine Interface for Spinal Cord Injury?

Research shows that miniaturized neural interfaces can help restore function and mobility in spinal cord injury by converting brain signals into electrical stimuli for the spinal cord, as demonstrated in rat models. This suggests potential effectiveness for the Intelligent Spine Interface in humans. ^{1 2 3 4 5}

Is the Intelligent Spine Interface generally safe for humans?

The safety reporting in clinical trials for spinal cord injury treatments, like the Intelligent Spine Interface, has been found to be suboptimal, with only 30% of trials providing satisfactory safety information. This means that while some safety data exists, it may not be comprehensive or detailed enough to fully assess the treatment's safety. ^{6 7 8 9 10}

How does the Intelligent Spine Interface treatment differ from other treatments for spinal cord injury?

The Intelligent Spine Interface is unique because it creates a digital bridge between the brain and spinal cord, allowing real-time communication to restore natural movement control after spinal cord injury. This approach uses advanced bioelectronics to convert brain signals into electrical stimuli for the spinal cord, enabling functions like standing and walking, which are not typically possible with other treatments. ^{2 5 11 12 13}

Research Team

David Borton, PhD

Principal Investigator

Brown University

Eligibility Criteria

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.

Inclusion Criteria

The injury site is at least 4 cm away from the end of the spinal cord.

I am between 18 and 65 years old.

Must provide informed consent prior to study participation

Exclusion Criteria

I have a birth defect or injury affecting my legs.

I have nerve damage in my legs or lower back issues.

I have a blood disorder or take medication that makes surgery unsafe.

Treatment Details

Interventions

• Intelligent Spine Interface (Other)

Trial Overview 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.

Participant Groups

Group I: SCI Patient Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Sarah Frost

Rhode Island Hospital

Chief Executive Officer

MBA from the University of Phoenix, BSc in Business Administration from the University of Arizona

G. Dean Roye

Rhode Island Hospital

Chief Medical Officer

MD

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Kameron Leigh Matthews

US Department of Veterans Affairs

Chief Medical Officer since 2021

MD from Johns Hopkins University

Doug Collins

US Department of Veterans Affairs

Secretary of Veterans Affairs

BA in Political Science from North Georgia College & State University

Brown University

Collaborator

Trials

480

Recruited

724,000+

Mukesh Jain

Brown University

Chief Medical Officer since 2022

MD from Harvard Medical School

Christina H. Paxson

Brown University

Chief Executive Officer since 2012

PhD in Economics from Columbia University

Intel Corporation

Industry Sponsor

Trials

10

Recruited

28,800+

Nuvectra

Industry Sponsor

Trials

3

Recruited

110+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

In a study involving eight human subjects, three user interfaces (head orientation, EMG from head and neck muscles, and a joystick) were tested for controlling a robotic arm in 3D space, showing that EMG commands could be a viable option for individuals with high tetraplegia.

Despite the sequential command strategy used by participants, which affected performance, EMG-based commands demonstrated potential for effective control of robotic arms, making it a promising candidate for future neuroprosthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of head orientation and neck muscle EMG signals as three-dimensional command sources. Williams, MR., Kirsch, RF.[2018]

The development of a miniaturized brain-machine-spinal cord interface (BMSI) shows promise for restoring mobility in individuals with spinal cord injuries by converting neural signals into electrical stimuli for the spinal cord.

In a proof-of-concept study with anesthetized rats, the BMSI successfully activated distinct muscle patterns through intraspinal microstimulation, demonstrating the potential for real-time control of movement based on brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical control of intraspinal microstimulation: Toward a new approach for restoration of function after spinal cord injury. Shahdoost, S., Frost, S., Dunham, C., et al.[2020]

The head movement image (HMI)-controlled computer mouse system significantly outperformed the infrared-controlled mouse system in various tasks during a clinical trial with nine spinal cord injured (SCI) participants, showing statistically significant improvements (p<0.05).

This new system allows individuals with disabilities to control the mouse cursor simply by wearing a headset and moving their heads, enhancing input speed and accessibility for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A head movement image (HMI)-controlled computer mouse for people with disabilities. Chen, YL., Chen, WL., Kuo, TS., et al.[2019]

Three cases of patients with high cervical cord injuries demonstrated the effectiveness of specialized computer interfaces for cursor control and clicking: a webcam-based Camera Mouse for a C4 patient, SmartNav 4AT for a C3 patient, and IntegraMouse for a C1 patient.

These findings highlight the importance of selecting appropriate input devices tailored to individual capabilities, which can significantly enhance rehabilitation and communication for patients with severe mobility limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The selection of the appropriate computer interface device for patients with high cervical cord injury. Kim, DG., Lee, BS., Lim, SE., et al.[2021]

The new pelvic orthosis device allows for direct mechanical interaction with the skeleton of rats during brain machine interface and rehabilitation studies without disrupting their normal stepping, as validated by statistical analysis of stepping parameters in 8 rats before and after implantation.

This method improves upon existing techniques by eliminating the need for slings or cuffs, which can alter sensory feedback, and supports efficient integration with robotic systems for enhanced rehabilitation and training in both intact and spinal cord injury models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pelvic implant orthosis in rodents, for spinal cord injury rehabilitation, and for brain machine interface research: construction, surgical implantation and validation. Udoekwere, UI., Oza, CS., Giszter, SF.[2021]

In a study of 171 patients with traumatic spinal cord injury (TSCI), over 77% experienced adverse events (AEs) during acute hospital care, with urinary tract infections and pneumonias being the most common, highlighting the need for improved monitoring and prevention strategies.

The presence of certain AEs, such as decubitus ulcers and delirium, significantly increased the length of hospital stay, indicating that these complications can lead to longer recovery times, although acute AEs did not impact health-related quality of life at the time of discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. Street, JT., Noonan, VK., Cheung, A., et al.[2015]

In a study of 444 adults with traumatic spinal cord injury, 79.3% experienced adverse events, with urinary tract infections and pneumonia being the most common, highlighting the high risk of complications in this patient group.

Older age and more severe injuries were linked to increased adverse events, while certain modifiable comorbidities, like substance use and psychiatric conditions, were associated with specific risks such as delirium and pneumonia, suggesting that addressing these factors could help reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study. Marion, TE., Rivers, CS., Kurban, D., et al.[2019]

The Model Spinal Cord Injury Systems (MSCIS) program has evolved since 1970, shifting its research focus from immediate medical treatments post-injury to broader social and environmental issues affecting individuals with spinal cord injuries, reflecting changing national priorities.

Current MSCIS research emphasizes advancements in medicine and technology aimed at improving recovery and physical functioning, which has raised care standards for spinal cord injury and encouraged further research and funding in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributions from the model systems programs to spinal cord injury research. Tate, DG., Forchheimer, M.[2019]

The development of a miniaturized brain-machine-spinal cord interface (BMSI) aims to restore mobility in individuals with spinal cord injuries by converting brain signals into electrical stimuli for the spinal cord, showing promise for functional recovery.

Initial studies in rats with spinal cord injuries demonstrate that the corticospinal interface can effectively record neural activity and stimulate muscle movement, indicating a potential pathway for re-establishing communication between the brain and spinal cord.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards a miniaturized brain-machine-spinal cord interface (BMSI) for restoration of function after spinal cord injury. Shahdoost, S., Frost, S., Van Acker, G., et al.[2020]

A brain-spine interface (BSI) was successfully developed to restore communication between the brain and spinal cord, allowing an individual with chronic tetraplegia to stand and walk naturally in various settings.

The BSI demonstrated high reliability over a year of use, and it not only enabled movement but also contributed to neurological recovery, allowing the participant to walk with crutches even when the device was turned off.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking naturally after spinal cord injury using a brain-spine interface. Lorach, H., Galvez, A., Spagnolo, V., et al.[2023]

Bioelectronic stimulation of the spinal cord shows promise in restoring motor function after spinal cord injuries, with advancements in technology allowing for better recording and generation of control signals from the uninjured spinal cord.

Challenges remain in the clinical application of spinal cord bioelectronic interfaces, including device manufacturing, surgical implantation, and managing the body's reaction to foreign materials, but solutions are being explored to improve long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord bioelectronic interfaces: opportunities in neural recording and clinical challenges. Jiang, L., Woodington, B., Carnicer-Lombarte, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of head orientation and neck muscle EMG signals as three-dimensional command sources. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Cortical control of intraspinal microstimulation: Toward a new approach for restoration of function after spinal cord injury. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A head movement image (HMI)-controlled computer mouse for people with disabilities. [2019]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

The selection of the appropriate computer interface device for patients with high cervical cord injury. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A pelvic implant orthosis in rodents, for spinal cord injury rehabilitation, and for brain machine interface research: construction, surgical implantation and validation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Epidemiology of persistent iatrogenic spinal cord injuries in Western Norway. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Previously Identified Common Post-Injury Adverse Events in Traumatic Spinal Cord Injury-Validation of Existing Literature and Relation to Selected Potentially Modifiable Comorbidities: A Prospective Canadian Cohort Study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Contributions from the model systems programs to spinal cord injury research. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Towards a miniaturized brain-machine-spinal cord interface (BMSI) for restoration of function after spinal cord injury. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Walking naturally after spinal cord injury using a brain-spine interface. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Spinal cord bioelectronic interfaces: opportunities in neural recording and clinical challenges. [2022]