Noninvasive Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen byAndrei Krassioukov, MD,PhD,FRCPC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Must not be taking: OnabotulinumtoxinA, others
Disqualifiers: Depression, PTSD, Bladder surgery, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you must notify the Principal Investigator if you start any new medications for bowel and lower urinary tract management during the study.
What data supports the effectiveness of the treatment Spinal Cord Neuromodulation (SCONE) for Transcutaneous Spinal Cord Stimulation (TSCS)?
Research shows that transcutaneous spinal cord stimulation (tSCS) can help improve muscle activation and voluntary movement in people with spinal cord injuries. Studies have found that tSCS can enhance motor function in both the upper and lower limbs, suggesting it may be a promising treatment for improving movement and strength.
12345Is noninvasive spinal cord stimulation generally safe for humans?
Transcutaneous spinal cord stimulation (tSCS) is considered relatively safe, with low rates of serious complications reported in studies. While some complications like infections or device issues can occur, they are rarely life-threatening or permanently disabling.
26789How is the SCONE treatment for spinal cord injury different from other treatments?
The SCONE treatment, which involves transcutaneous spinal cord stimulation (tSCS), is unique because it is a non-invasive method that uses electrodes to stimulate the spinal cord and promote motor recovery. Unlike traditional rehabilitation methods, tSCS can enhance voluntary movement and muscle strength without surgery, making it a promising option for improving function in individuals with spinal cord injury.
2351011Eligibility Criteria
This trial is for adults with recent spinal cord injuries (3-6 months ago) who are experiencing issues with bladder, bowel, sexual function, or muscle spasms. It's taking place in Canada and Ukraine. Participants will join a study lasting about 33 weeks to see if non-invasive spine stimulation helps improve these functions.Inclusion Criteria
My spinal injury level is between C5 and T10 and is classified as severe or moderate.
My spinal cord injury occurred between 3 to 6 months ago.
I have documented issues with bladder function.
+5 more
Exclusion Criteria
I haven't had Botox injections in my bladder or sphincter muscles in the last 9 months.
I show symptoms of nerve damage in my muscles.
I have cognitive impairments or psychological issues.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Phase 1
Group 1 receives therapeutic TSCS and Group 2 receives sham stimulation for 8 weeks
8 weeks
24 visits (in-person)
Treatment Phase 2
Group 1 continues TSCS therapy and Group 2 switches to therapeutic TSCS for another 8 weeks
8 weeks
24 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
8 weeks
10 visits (in-person)
Participant Groups
The SCONE™ device for transcutaneous spinal cord stimulation (TSCS) is being tested. Participants are split into two groups: one gets real TSCS plus regular rehab for 16 weeks; the other starts with fake stimulation then switches to real TSCS after 8 weeks.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 TreatmentExperimental Treatment1 Intervention
TSCS at or between cervical spinal segment 5 (C5) and thoracic spinal segment 10 (T10) at Intervention Phases 1 and 2, 8 weeks each.
Group II: Group 2 ShamPlacebo Group1 Intervention
TSCS at or between C5 and T10 at Intervention Phase 2; 8 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Blusson Spinal Cord CentreVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
United States Department of DefenseCollaborator
Rivne Regional War Veterans Hospital, Spinal Cord Injury Rehabilitation CenterCollaborator
References
A novel percutaneous technique to implant plate-type electrodes. [2012]In spinal cord stimulation (SCS) mainly 2 distinctive implantation techniques can be recognized: the percutaneous and surgical technique.
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]Transcutaneous spinal cord stimulation (tSCS) is a non-invasive modality in which electrodes can stimulate spinal circuitries and facilitate a motor response. This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI) and to appraise the quality of included trials.
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]Cervical transcutaneous spinal cord stimulation (tSCS) is a rehabilitation tool which has been used to promote upper-limb motor recovery after spinal cord injury. Importantly, optimizing sensory fiber activation at specific spinal segments could enable activity-dependent neuromodulation during rehabilitation.
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCS) on upper and lower extremity function in individuals with chronic spinal cord injury (SCI).
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]Background. Epidural spinal electrical stimulation at the lumbar spinal level evokes rhythmic muscle activation of lower-limb antagonists, attributed to the central pattern generator. However, the efficacy of noninvasive spinal stimulation for the activation of lower-limb muscles is not yet clear. This review aimed to analyze the feasibility and efficacy of noninvasive transcutaneous spinal cord stimulation (tSCS) on motor function in individuals with spinal cord injury. Methods. A search for tSCS studies was made of the following databases: PubMed; Cochrane Registry; and Physiotherapy Evidence Database (PEDro). In addition, an inverse manual search of the references cited by the identified articles was carried out. The keywords transcutaneous, non-invasive, electrical stimulation, spinal cord stimulation [Mesh term], and spinal cord injury were used. Results. A total of 352 articles were initially screened, of which 13 studies met the inclusion criteria for systematic review. The total participant sample comprised 55 persons with spinal cord injury. All studies with tSCS provided evidence of induced muscle activation in the lower and upper limbs, and applied stimulation at the level of the T11-T12 and C4-C7 interspinous space, respectively. All studies reported an increase in motor response measured by recording surface electromyography, voluntary movement, muscle strength, or function. Conclusions. Although this review highlights tSCS as a feasible therapeutic neuromodulatory strategy to enhance voluntary movement, muscle strength, and function in patients with chronic spinal cord injury, the clinical impact and efficacy of electrode location and current intensity need to be characterized in statistically powered and controlled clinical trials.
Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]OBJECTIVE Cervical spinal cord stimulation (cSCS) is used to treat pain of the cervical region and upper extremities. Case reports and small series have shown a relatively low risk of complication after cSCS, with only a single reported case of perioperative spinal cord injury in the literature. Catastrophic cSCS-associated spinal cord injury remains a concern as a result of underreporting. To aid in preoperative counseling, it is necessary to establish a minimum rate of spinal cord injury and surgical complication following cSCS. METHODS The Nationwide Inpatient Sample (NIS) is a stratified sample of 20% of all patient discharges from nonfederal hospitals in the United States. The authors identified discharges with a primary procedure code for spinal cord stimulation (ICD-9 03.93) associated with a primary diagnosis of cervical pathology from 2002 to 2011. They then analyzed short-term safety outcomes including the presence of spinal cord injury and neurological, medical, and general perioperative complications and compared outcomes using univariate analysis. RESULTS Between 2002 and 2011, there were 2053 discharges for cSCS. The spinal cord injury rate was 0.5%. The rates of any neurological, medical, and general perioperative complications were 1.1%, 1.4%, and 11.7%, respectively. There were no deaths. CONCLUSIONS In the largest series of cSCS, the risk of spinal cord injury was higher than previously reported (0.5%). Nonetheless, this procedure remains relatively safe, and physicians may use these data to corroborate the safety of cSCS in an appropriately selected patient population. This may become a key treatment option in an increasingly opioid-dependent, aging population.
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]Spinal cord stimulation (SCS) has been proven effective for multiple chronic pain syndromes. Over the past 40 years of use, the complication rates of SCS have been well defined in the literature; however, the incidence of one of the most devastating complications, spinal cord injury (SCI), remains largely unknown. The goal of the study was to quantify the incidence of SCI in both percutaneous and paddle electrode implantation.
New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]The most common complications of spinal cord stimulation (SCS) therapy are generally related to surgical site infection and hardware malfunction. Less well understood are the adverse neurological effects of this therapy. We present the case of a patient who underwent placement of a Senza HF10 high-frequency spinal cord stimulator with subsequent development of tinnitus, vertigo, intermittent involuntary left facial twitches, and perioral numbness. These symptoms resolved following deactivation of her device. To further explore these less common neurologic complications of SCS therapy, a review of literature and a review of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database are included. Further research and investigation in this area are needed so that clinicians and patients may have more complete knowledge and understanding of the potential treatment-limiting complications of spinal cord stimulation.
Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice. [2018]Spinal cord stimulation provides analgesia through electrical stimulation of the dorsal column of the spinal cord via electrode leads placed into the epidural space. In traditional tonic stimulation, a painful sensation is replaced with paraesthesia. Spinal cord stimulation is effective in reducing neuropathic pain, enhancing function, and improving quality of life in different chronic pain conditions. Currently, there is most evidence to support its use for failed back surgery syndrome when multidisciplinary conventional management is unsuccessful. Temporary trial leads are inserted in carefully selected patients to test their responsiveness prior to permanent implantation. Newer neuromodulation modalities are now available. These include burst stimulation, high-frequency stimulation, and dorsal root ganglion stimulation. Results are encouraging to date, and they may provide superior analgesia and cover for deficiencies of traditional tonic stimulation. Although complications are not uncommon, they are rarely life threatening or permanently disabling. Nonetheless, device removal is occasionally needed.
Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023]Transcutaneous spinal cord stimulation (tSCS) has been gaining momentum as a non-invasive rehabilitation approach to restore movement to paralyzed muscles after spinal cord injury (SCI). However, its low selectivity limits the types of movements that can be enabled and, thus, its potential applications in rehabilitation.
Trans-Spinal Electrical Stimulation Therapy for Functional Rehabilitation after Spinal Cord Injury: Review. [2022]Spinal cord injury (SCI) is one of the most debilitating injuries in the world. Complications after SCI, such as respiratory issues, bowel/bladder incontinency, pressure ulcers, autonomic dysreflexia, spasticity, pain, etc., lead to immense suffering, a remarkable reduction in life expectancy, and even premature death. Traditional rehabilitations for people with SCI are often insignificant or ineffective due to the severity and complexity of the injury. However, the recent development of noninvasive electrical neuromodulation treatments to the spinal cord have shed a ray of hope for these individuals to regain some of their lost functions, a reduction in secondary complications, and an improvement in their life quality. For this review, 250 articles were screened and about 150 were included to summarize the two most promising noninvasive spinal cord electrical stimulation methods of SCI rehabilitation treatment, namely, trans-spinal direct current stimulation (tsDCS) and trans-spinal pulsed current stimulation (tsPCS). Both treatments have demonstrated good success in not only improving the sensorimotor function, but also autonomic functions. Due to the noninvasive nature and lower costs of these treatments, in the coming years, we expect these treatments to be integrated into regular rehabilitation therapies worldwide.