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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new implant called IST-12, designed to help people with spinal cord injuries regain hand and arm function. The implant uses a stimulator and sensor to test if it can improve movement when activated. The trial consists of two stages: one with the stimulator off and another with it on. It seeks individuals with a cervical spinal cord injury (at the neck level) who have been injured for at least a year and have stable conditions, such as spasticity (muscle stiffness), controlled by medication. Participants should be able to use a wheelchair and have a supportive home environment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

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 prior data suggests that this implant is safe for spinal cord injury?

A previous study tested the IST-12 device, which helps improve hand and arm movement, on 12 people with spinal cord injuries. The study found no major safety issues. However, other research on similar devices has identified serious problems. Out of 520 reported issues, most were severe or life-threatening.

Additionally, placing these devices can sometimes cause temporary pain, infection, or fluid leaks in the spine area. While the IST-12 appears safe based on current information, risks remain, as with any medical procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IST-12 implant for spinal cord injury because it offers a new approach by using electrical stimulation directly at the injury site. Unlike current treatments that primarily rely on rehabilitation and physical therapy, the IST-12 implant actively stimulates nerve pathways to potentially restore function. This method could enhance mobility and sensation, providing hope for improved quality of life for individuals with spinal cord injuries. The ability to toggle the stimulation on and off also allows for precise control and adjustment based on each patient's progress and needs.

What evidence suggests that the IST-12 implant is effective for spinal cord injury?

Research has shown that spinal cord stimulation can greatly enhance hand and arm movement in individuals with neck-level spinal cord injuries. One study found that patients experienced noticeable improvements in function within three months, with benefits lasting for years. Another study confirmed that a similar treatment was safe and effective in enhancing hand and arm functions for these patients. While some research suggests limited effects for back pain, the focus here is on the positive results for arm and hand function in spinal cord injury patients. This trial will evaluate the IST-12 implant, with participants experiencing either the "Stimulation ON" or "Stimulation OFF" treatment arms, to assess its potential to improve movement for those with neck-level spinal cord injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Kevin L Kilgore, Ph.D.

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ... The study is remarkable in that 81.2% of patients randomized to DRG SCS achieved success at 3 months, compared with 55.7% in those who received conventional ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715921064321

Systematic Literature Review of Spinal Cord Stimulation in ... In fact, based on the reported data, pain relief and functional improvements occur as early as three months and are sustained long term, even multiple years ...

3. sydney.edu.au sydney.edu.au/news-opinion/news/2023/03/07/spinal-cord-stimulation-doesn-t-help-with-back-pain-says-new-rev.html

Spinal cord stimulation doesn t help with back pain says ... The review concluded that spinal cord stimulation is no better than a placebo for treating low back pain, with probably little to no benefit for people with ...

4. mdpi.com mdpi.com/2076-3417/15/15/8488

Reviewing Breakthroughs and Limitations of Implantable ... This research is going to analyse and review these current treatment methods for spinal cord injury and identify the current gaps and limitations in these, such ...

5. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9329040/

Spinal Cord Stimulators: An Analysis of the Adverse Events ... Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715924000709

Implanted Pulse Generators in Lower Extremity ... The objective of this study is to analyze the outcomes of implanted pulse generators that our research group installed in volunteers with paralysis.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/p130022b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Risks associated with SCS system placement procedures: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage, CSF fistula, epidural.

9. tandfonline.com tandfonline.com/doi/full/10.1080/01616412.2020.1798106

Neuroprosthesis for individuals with spinal cord injury The IST-12 consisted of 12 stimulation channels and two channels of myoelectric signal recording acquisition. Twelve subjects were implanted with the IST-12 ...

10. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2799839

Assessment of Safety of a Fully Implanted Endovascular ... This case series assesses the safety of an endovascular brain-computer interface and feasibility of using the system to control a computer ...