SCONE Device for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen byMichael J Berger, MD, FRCPC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Michael Berger
Must not be taking: Antidepressants, Baclofen
Disqualifiers: Ventilator dependent, Depression, Drug abuse, others
No Placebo Group
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.
12345How 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.
678910Eligibility 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
+9 more
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.
+8 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Transcutaneous Spinal Cord StimulationExperimental Treatment1 Intervention
Transcutaneous spinal cord stimulation (TSCS) will be delivered using a portable non-invasive spinal cord stimulator (SCONE, SpineX Inc., CA, USA).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ICORD, Blusson Spinal Cord CentreVancouver, Canada
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Who Is Running the Clinical Trial?
Michael BergerLead Sponsor
Vancouver Coastal Health Research InstituteCollaborator
International Collaboration on Repair DiscoveriesCollaborator
SpineX Inc.Industry Sponsor
Vancouver Coastal HealthCollaborator
University of British ColumbiaCollaborator
Rick Hansen FoundationCollaborator
References
Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. [2015]Adverse events (AEs) with significant resultant morbidity are common during the acute hospital care of patients with traumatic spinal cord injury (TSCI). The Rick Hansen SCI Registry (RHSCIR) collects Canada-wide data on patients with TSCI, such as sociodemographic, injury, diagnosis, intervention, and health outcome details. These data contribute to an evidence base for informing best practice and improving SCI care. As the RHSCIR captures data on patients from prehospital to community phases of care, it is an invaluable resource for providing information on health outcomes resulting from TSCI, including outcomes related to AEs.
A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]Accurate safety information in published clinical trials guides the assessment of risk-benefit, as well as the design of future clinical trials. Comprehensive reporting of adverse events, toxicity, and discontinuations from acute spinal cord injury clinical trials is an essential step in this process. Here, we sought to assess the degree of "satisfactoriness" of reporting in past clinical trials in spinal cord injury. A review of citations from MEDLINE and EMBASE identified eligible clinical trials in acute (within 30 days) spinal cord injury. English language studies, published between 1980 and 2020, with sensory, motor, or autonomic neurological assessments as the primary outcome measure were eligible for inclusion. Criteria were then established to qualify the safety reporting as satisfactory (i.e., distinguished severe/life-threatening events), partially satisfactory, or unsatisfactory (i.e., only mentioned in general statements, or reported but without distinguishing severe events). A total of 40 trials were included. Satisfactory reporting for clinical adverse events was observed in 30% of trials; partially satisfactory was achieved by 10% of the trials, and the remaining 60% were unsatisfactory. The majority of trials were determined to be unsatisfactory for the reporting of laboratory-defined toxicity (82.5%); only 17.5% were satisfactory. Discontinuations were satisfactorily reported for the majority of trials (80%), with the remaining partially satisfactory (5%) or unsatisfactory (15%). Reporting of safety in clinical trials for acute spinal cord injury is suboptimal. Due to the complexities of acute spinal cord injury (e.g., polytrauma, multiple systems affected), tailored and specific standards for tracking adverse events and safety reporting should be established.
Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury. [2015]McClure LA, Boninger ML, Oyster ML, Williams S, Houlihan B, Lieberman JA, Cooper RA. Wheelchair repairs, breakdown, and adverse consequences for people with traumatic spinal cord injury.
Epidemiology of persistent iatrogenic spinal cord injuries in Western Norway. [2021]Iatrogenic spinal cord injuries (SCIs) caused by invasive procedures or surgical interventions have previously been reported as case studies. The primary objective of this study was to investigate and analyze the incidence, etiology, and prognosis of iatrogenic SCI in Western Norway.
The Efficacy, Adverse Events, and Withdrawal Rates of the Pharmacological Management of Chronic Spinal Cord Injury Pain: A Systematic Review and Meta-Analysis. [2022]To establish the efficacy of medications, incidence of adverse events (AEs), and withdrawal rates associated with the pharmacological management of chronic spinal cord injury pain.
Traumatic quadriplegia: follow-up study of self-care skills. [2004]In this study to assess the extent of use of the self-care skills learned during rehabilitation and of the orthotic devices provided to support function once community living was resumed, 35 persons with traumatic cervical cord injury were tested in the home environment 1 to 4 years after discharge from the hospital. Of this group, 20 had a functional spinal cord level of C6 or C7 and 15 of C4 or C5. The results indicated that the level of self-care achieved during rehabilitation was maintained by the majority of persons at follow-up. The areas most sensitive to change were toileting and bathing, desk skills, grooming, transfers and upper and lower extremity dressing for those with C6 or C7 functional spinal cord levels, and grooming, written communication and desk skills for those with C4 or C5 levels. The majority continued to use at least some of the prescribed upper extremity orthotics and assistive devices. Neither hand surgery nor equipment use was clearly related to functional status. The ratchet hand splint was well accepted by the C4-5 group. Changes in performance are discussed in terms of a restructuring of personal priorities, the availability of interpersonal support, and architectural and attitudinal barriers within the community.
Electronic device use by individuals with traumatic spinal cord injury. [2018]To describe use of several electronic devices among individuals with traumatic spinal cord injury (SCI).
Sensor Fusion to Infer Locations of Standing and Reaching Within the Home in Incomplete Spinal Cord Injury. [2020]The objective of rehabilitation after spinal cord injury is to enable successful function in everyday life and independence at home. Clinical tests can assess whether patients are able to execute functional movements but are limited in assessing such information at home. A prototype system is developed that detects stand-to-reach activities, a movement with important functional implications, at multiple locations within a mock kitchen.
Advances in the clinical application of orthotic devices for stroke and spinal cord injury since 2013. [2023]Stroke and spinal cord injury are common neurological disorders that can cause various dysfunctions. Motor dysfunction is a common dysfunction that easily leads to complications such as joint stiffness and muscle contracture and markedly impairs the daily living activities and long-term prognosis of patients. Orthotic devices can prevent or compensate for motor dysfunctions. Using orthotic devices early can help prevent and correct deformities and treat muscle and joint problems. An orthotic device is also an effective rehabilitation tool for improving motor function and compensatory abilities. In this study, we reviewed the epidemiological characteristics of stroke and spinal cord injury, provided the therapeutic effect and recent advances in the application of conventional and new types of orthotic devices used in stroke and spinal cord injury in different joints of the upper and lower limbs, identified the shortcomings with these orthotics, and suggested directions for future research.
Design of a 3D-printed, open-source wrist-driven orthosis for individuals with spinal cord injury. [2019]Assistive technology, such as wrist-driven orthoses (WDOs), can be used by individuals with spinal cord injury to improve hand function. A lack of innovation and challenges in obtaining WDOs have limited their use. These orthoses can be heavy and uncomfortable for users and also time-consuming for orthotists to fabricate. The goal of this research was to design a WDO with user (N = 3) and orthotist (N = 6) feedback to improve the accessibility, customizability, and function of WDOs by harnessing advancements in 3D-printing. The 3D-printed WDO reduced hands-on assembly time to approximately 1.5 hours and the material costs to $15 compared to current fabrication methods. Varying improvements in users' hand function were observed during functional tests, such as the Jebsen Taylor Hand Function Test. For example, one participant's ability on the small object task improved by 29 seconds with the WDO, while another participant took 25 seconds longer to complete this task with the WDO. Two users had a significant increase in grasp strength with the WDO (13-122% increase), while the other participant was able to perform a pinching grasp for the first time. The WDO designs are available open-source to increase accessibility and encourage future innovation.