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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called SCONE, designed to help individuals with spinal cord injuries or multiple system atrophy manage orthostatic hypotension (a drop in blood pressure when standing) and bowel issues. Researchers aim to determine if this non-invasive device can be safely used at home. Participants will initially try the treatment at a study center and then continue it at home for several weeks. This trial may suit individuals living in British Columbia with a chronic spinal cord injury or multiple system atrophy, particularly if they have experienced these conditions for over a year. As an unphased trial, this study offers a unique opportunity to contribute to early research on a potentially life-improving device.

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.

What prior data suggests that the SCONE device is safe for individuals with spinal cord injury or multiple system atrophy?

Research has shown that transcutaneous spinal cord stimulation (tSCS), such as the SCONE device, is generally safe for individuals with spinal cord injuries. Studies have found that this therapy, particularly when combined with activity-based therapy, does not cause serious side effects. Specifically, one study noted that after 12 weeks of a similar therapy, no major safety concerns arose. Another study found that using this type of therapy, both in clinics and at home, is safe and can enhance strength and function in individuals with long-term spinal cord injuries. These findings suggest that SCONE therapy is likely well-tolerated and safe for home use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SCONE device for spinal cord injuries because it offers a non-invasive treatment option through transcutaneous spinal cord stimulation (TSCS). Unlike traditional methods that might involve surgery or medications to manage symptoms, the SCONE device delivers electrical stimulation through the skin using a portable device. This approach not only potentially reduces risks associated with invasive procedures but also allows for greater accessibility and ease of use for patients. By targeting the spinal cord directly, the SCONE device could enhance nerve function and improve mobility, offering a promising new avenue for individuals with spinal cord injuries.

What evidence suggests that the SCONE device is effective for spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (tSCS), administered in this trial using the SCONE device, can help individuals with spinal cord injuries enhance their abilities. Studies have found that combining tSCS with other treatments can improve movement and function recovery. For instance, participants have reported stronger leg muscles and better walking ability after using tSCS. One study found that tSCS was more effective when used for a longer duration alongside other therapies. While the primary focus is often on movement, tSCS might also assist with issues like blood pressure and bowel function. Overall, early research suggests that tSCS could benefit various functions affected by spinal cord injury. ^{2 5 6 7 8}

Who Is on the Research Team?

Michael J Berger, MD, FRCPC

Principal Investigator

The University of British Columbia

Andrei Krassioukov, MD, FRCPC

Principal Investigator

The University of British Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Effectiveness of Transcutaneous Spinal Cord Stimulation for ... This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, or other ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

3. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01545-8

Transcutaneous spinal cord stimulation combined with robotic ... The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in ...

5. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998450

Safety and Effectiveness of Multisite Transcutaneous ... These findings indicate that prolonged training with tSCS-ABT can be an effective neuromodulatory intervention for individuals with SCI.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05301335

Spinal COrd NeuromodulaTor by SpIneX and ScoNE to ... The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Clinic and home-based ARC EX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.