IST-12 Implant for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must be taking: Spasticity medications

Disqualifiers: Immunologic diseases, Cardiac arrhythmias, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that spasticity should be controlled with medication if applicable, suggesting that some medications may be continued.

What data supports the effectiveness of the IST-12 treatment for spinal cord injury?

The study on the Neuro-Spinal Scaffold (NSS), a similar implantable device, showed potential benefits for safety and neurological recovery in patients with complete thoracic spinal cord injury, suggesting that implantable treatments like IST-12 might also be effective. ^{1 2 3 4 5}

Is the IST-12 implant generally safe for humans?

The Neuro-Spinal Scaffold (NSS), similar to the IST-12 implant, was found to be safe in patients with complete thoracic spinal cord injury in a study, with no major safety concerns reported over a 6-month period. ^{5 6 7 8 9}

How does the IST-12 treatment for spinal cord injury differ from other treatments?

The IST-12 treatment is unique because it involves a fully implantable stimulator for spinal cord stimulation, which is batteryless and allows for wireless power and data transmission, making it more efficient for long-term use compared to traditional methods. This approach is designed to facilitate functional recovery by stimulating the spinal cord directly, which is different from other treatments that may not offer such direct and programmable stimulation. ^{10 11 12 13 14}

Research Team

Kevin L Kilgore, Ph.D.

Principal Investigator

MetroHealth Medical Center

Eligibility Criteria

This trial is for adults aged 18-60 with a spinal cord injury between C5-C8, who are at least one year post-injury without additional function recovery. Participants must have good vision, joint mobility in the upper extremity, controlled spasticity if applicable, and be able to use a wheelchair with trunk support. They should not have major chronic infections or illnesses that increase surgery risks.

Inclusion Criteria

I can see clearly with both eyes.

I can use a wheelchair and have enough upper body control to use both hands.

I don't have any stiff joints that could interfere with treatments.

Exclusion Criteria

I do not have uncontrolled seizures.

I do not have immune, heart rhythm problems, undiagnosed breast lumps, skin conditions, or major organ failure.

I currently have an infection that has not gone away.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 days

1 visit (in-person)

Pre-surgical Exercise

Participants undergo pre-surgical exercise to prepare for implantation

2 weeks

Implantation Surgery

Surgical placement of the implantable stimulator in the upper extremity

1 day

1 visit (in-person)

Post-surgical Hospitalization

Participants are hospitalized for recovery after surgery

3-7 days

Exercise Program

Participants engage in an exercise program to enhance recovery

8 weeks

Training Program

Participants undergo a training program to learn to use the stimulator

12 weeks

Active Rehabilitation

Participants are actively involved in rehabilitation activities

12 weeks

Follow-up

Participants are monitored quarterly for one year and annually thereafter

1 year

Quarterly visits (in-person)

Long-term Follow-up

Participants are followed for life after the initial follow-up period

Treatment Details

Interventions

• IST-12

Trial Overview The study tests an implanted device called IST-12 designed to restore hand and arm functions in individuals with cervical level spinal cord injuries. The effectiveness of this stimulator and sensor will be evaluated through periodic testing in a laboratory setting.

Participant Groups

Group I: Stimulation ON Experimental Treatment 1 Intervention

Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.

Group II: Stimulation OFF Active Control 1 Intervention

Function with stimulation turned off.

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

VA Office of Research and Development

Collaborator

Trials

1,691

Recruited

3,759,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

FDA Office of Orphan Products Development

Collaborator

Trials

73

Recruited

6,400+

Findings from Research

In a study involving 19 patients with complete thoracic spinal cord injury, the Neuro-Spinal Scaffold (NSS) implantation was found to be safe, with no serious adverse effects reported over a 24-month follow-up period.

44% of evaluable patients showed neurological improvement, with some achieving higher ASIA Impairment Scale grades at 12 and 24 months, indicating potential long-term benefits of the NSS in promoting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. Kim, KD., Lee, KS., Coric, D., et al.[2023]

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]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

Spinal cord stimulation has become a well-established treatment for neuropathic and vasculopathic pain syndromes, particularly after other treatments have failed, with about 1700 systems implanted annually in Germany.

The therapy's introduction in Germany in the early 1970s was significantly influenced by pioneers like Jörg-Ulrich Krainick, Uwe Thoden, and Wolfhard Winkelmüller, marking a critical development in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of epidural spinal cord stimulation. Fortieth anniversary of the first implantation in Germany]. Tronnier, V., Richter, HP., Winkelmüller, W.[2021]

A new fully implantable epidural spinal cord stimulation (ESCS) system has been developed for use in rats, allowing researchers to study the neural mechanisms of recovery after spinal cord injury (SCI) in a more practical and efficient way.

This innovative system is programmable and batteryless, enabling chronic experiments without the need for tethering, which could lead to better understanding and advancements in treatments for functional recovery in individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fully Implantable Stimulator With Wireless Power and Data Transmission for Experimental Investigation of Epidural Spinal Cord Stimulation. Xu, Q., Hu, D., Duan, B., et al.[2015]

References

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

Characterizing Natural Recovery of People With Initial Motor Complete Tetraplegia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Natural history of neurological improvement following complete (AIS A) thoracic spinal cord injury across three registries to guide acute clinical trial design and interpretation. [2023]

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

Treatment with implant-supported fixed dental prostheses in patients with congenital and acquired neurologic disabilities: a prospective study. [2018]

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

Does improvement in AIS grade correlate with functional recovery in all patients with a traumatic Spinal Cord Injury? [2023]

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

A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study. [2023]

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

Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Intraoperative neurophysiological monitoring and spinal cord stimulator implantation. [2023]

8. 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]

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

[Development of epidural spinal cord stimulation. Fortieth anniversary of the first implantation in Germany]. [2021]

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

A Fully Implantable Stimulator With Wireless Power and Data Transmission for Experimental Investigation of Epidural Spinal Cord Stimulation. [2015]

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

Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells. [2018]

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

The Fabrication, Implantation, and Stability of Intraspinal Microwire Arrays in the Spinal Cord of Cat and Rat. [2017]

14. England pubmed.ncbi.nlm.nih.gov

Evaluation of an innovative spinal cord stimulator platform for the treatment of chronic pain. [2019]