SCONE Device for Spinal Cord Injury

Overseen By Andrei Krassioukov, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Berger

Must not be taking: Antidepressants, Baclofen

Disqualifiers: Ventilator dependent, Depression, Drug abuse, others

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

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

6 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are: * To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre * To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction Participation will last approximately 10 weeks (excluding screening period) and involves * Attending the study center to collect baseline evaluations and to plan where electrodes will be placed * A 2 week treatment period at the centre with 3 visits per week * A 6 week home based therapy period involving 1 hour treatments twice a day * Attending the study center to collect post-treatment evaluations

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using any medication or treatment that the investigator believes is not in your best interest for the study, you may be excluded from participating.

Is the SCONE Device for Spinal Cord Injury safe for humans?

There is no specific safety data available for the SCONE Device for Spinal Cord Injury in the provided research articles. ^{1 2 3 4 5}

How is the SCONE treatment for spinal cord injury different from other treatments?

The SCONE treatment for spinal cord injury is unique because it likely involves a novel device or approach, as there is no mention of standard treatments for this condition in the provided research. This suggests that SCONE may offer a new way to support or enhance function in individuals with spinal cord injuries, potentially through innovative technology or methods not covered by existing orthotic devices or rehabilitation techniques. ^{6 7 8 9 10}

Research Team

Andrei Krassioukov, MD, FRCPC

Principal Investigator

The University of British Columbia

Michael J Berger, MD, FRCPC

Principal Investigator

The University of British Columbia

Eligibility Criteria

This trial is for individuals with spinal cord injury or multiple system atrophy who experience orthostatic hypotension and bowel dysfunction. Participants will engage in a home-based therapy using the SCONE device over approximately 10 weeks, including visits to the study center.

Inclusion Criteria

I am between 19 and 70 years old.

Resident of British Columbia, Canada with active provincial medical services plan

Willing and able to comply with all clinic visits and study-related procedures

Exclusion Criteria

Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse

I have not had severe anemia or low blood volume in the last 6 months.

I have had surgery to implant electrodes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessments

Baseline evaluations and EMG mapping of spinal cord segments with transcutaneous spinal cord stimulation

1 week

2 visits (in-person)

Treatment

Transcutaneous spinal cord stimulation at the center

2 weeks

3 visits per week (in-person)

Home-based Therapy

Home-based therapy involving 1-hour treatments twice a day

6 weeks

Post-treatment Assessments

Post-treatment autonomic and cardiac function assessments

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SCONE

Trial Overview The SCONE device is being tested as a home-based treatment for orthostatic hypotension and bowel dysfunction. The study involves initial training at a research center, followed by a two-week on-site treatment period and six weeks of self-administered therapy at home.

Participant Groups

Group I: Transcutaneous Spinal Cord Stimulation Experimental Treatment 1 Intervention

Transcutaneous spinal cord stimulation (TSCS) will be delivered using a portable non-invasive spinal cord stimulator (SCONE, SpineX Inc., CA, USA).

Who Is Running the Clinical Trial?

Michael Berger

Lead Sponsor

Trials

1

Recruited

6+

Vancouver Coastal Health Research Institute

Collaborator

Trials

30

Recruited

5,600+

International Collaboration on Repair Discoveries

Collaborator

Trials

9

Recruited

230+

SpineX Inc.

Industry Sponsor

Trials

4

Recruited

240+

Vancouver Coastal Health

Collaborator

Trials

41

Recruited

717,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Rick Hansen Foundation

Collaborator

Trials

8

Recruited

130+

Findings from Research

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]

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]

In a study of 2,213 full-time wheelchair users with spinal cord injuries, nearly 45% experienced wheelchair repairs within six months, and 8.7% faced adverse consequences from breakdowns, highlighting a significant issue for this population.

Power wheelchair users had a notably higher frequency of repairs and adverse consequences compared to manual wheelchair users, indicating that the type of wheelchair may influence reliability and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. McClure, LA., Boninger, ML., Oyster, ML., et al.[2015]

In a review of 183 patients over a 10-year period, 12.5% experienced iatrogenic spinal cord injuries (SCIs), primarily due to cervical spinal stenosis surgeries, indicating a significant risk associated with certain medical procedures.

Despite a low annual incidence rate of 2.3 per 1,000,000, the consequences of iatrogenic SCIs are severe, with most patients showing incomplete injuries and no complete recoveries, highlighting the need for increased awareness and preventive measures in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of persistent iatrogenic spinal cord injuries in Western Norway. Æsøy, MS., Solvang, SH., Grønning, M., et al.[2021]

Pregabalin was found to be effective for managing neuropathic pain in chronic spinal cord injury patients, with strong evidence from multiple studies, while cannabinoids were deemed ineffective for the same condition.

Adverse events (AEs) such as dizziness and somnolence were common, leading to withdrawal rates that varied significantly across different medication types, highlighting the need for better reporting of AEs in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy, Adverse Events, and Withdrawal Rates of the Pharmacological Management of Chronic Spinal Cord Injury Pain: A Systematic Review and Meta-Analysis. Canavan, C., Inoue, T., McMahon, S., et al.[2022]

A study of 35 individuals with traumatic cervical cord injury showed that most maintained their self-care skills learned during rehabilitation 1 to 4 years after hospital discharge, particularly in areas like toileting and grooming.

The majority of participants continued to use prescribed orthotic devices, indicating their ongoing importance in supporting function, although the use of these devices did not directly correlate with improved functional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic quadriplegia: follow-up study of self-care skills. Rogers, JC., Figone, JJ.[2004]

A survey of 451 individuals with traumatic spinal cord injury revealed that those with high-level tetraplegia were less likely to use tablet and handheld electronic devices compared to individuals with other levels of injury.

Older adults (65 years and older) were also less likely to own or use tablet computers and handheld devices, indicating that age and injury severity influence the adoption of technology among individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic device use by individuals with traumatic spinal cord injury. Mayman, G., Perera, M., Meade, MA., et al.[2018]

A new prototype system accurately detects stand-to-reach activities in individuals with incomplete spinal cord injuries, achieving an impressive 98% accuracy in identifying these movements in a mock kitchen setting.

By combining a thigh-mounted accelerometer and a network of radio frequency tags, this system allows for effective monitoring of functional movements at home, potentially improving rehabilitation assessments and patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor Fusion to Infer Locations of Standing and Reaching Within the Home in Incomplete Spinal Cord Injury. Lonini, L., Reissman, T., Ochoa, JM., et al.[2020]

Orthotic devices are crucial in managing motor dysfunction caused by stroke and spinal cord injuries, as they can prevent deformities and improve rehabilitation outcomes when used early.

The study highlights both conventional and new orthotic devices' effectiveness in treating joint and muscle issues, while also identifying areas for improvement and future research in orthotic technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the clinical application of orthotic devices for stroke and spinal cord injury since 2013. Cui, Y., Cheng, S., Chen, X., et al.[2023]

The newly designed 3D-printed wrist-driven orthoses (WDOs) significantly reduced fabrication time to about 1.5 hours and material costs to $15, making them more accessible and customizable for users with spinal cord injuries.

User testing showed varying improvements in hand function, with some participants experiencing up to a 122% increase in grasp strength, highlighting the potential effectiveness of the WDOs in enhancing hand function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a 3D-printed, open-source wrist-driven orthosis for individuals with spinal cord injury. Portnova, AA., Mukherjee, G., Peters, KM., et al.[2019]

References

1. 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]

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

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

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

Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. [2015]

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

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

5. England pubmed.ncbi.nlm.nih.gov

The Efficacy, Adverse Events, and Withdrawal Rates of the Pharmacological Management of Chronic Spinal Cord Injury Pain: A Systematic Review and Meta-Analysis. [2022]

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

Traumatic quadriplegia: follow-up study of self-care skills. [2004]

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

Electronic device use by individuals with traumatic spinal cord injury. [2018]

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

Sensor Fusion to Infer Locations of Standing and Reaching Within the Home in Incomplete Spinal Cord Injury. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in the clinical application of orthotic devices for stroke and spinal cord injury since 2013. [2023]

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

Design of a 3D-printed, open-source wrist-driven orthosis for individuals with spinal cord injury. [2019]