The Krassioukov lab is conducting a pilot study investigating the safety and feasibility of a new investigational device called SCONE— a portable non-invasive electrical device that provides transcutaneous spinal cord stimulation (tSCS) by electrodes connected to a battery-powered source which then goes on to activate and amplify circuitry that controls autonomic and motor function of organs throughout the body.
The goal of this study is to evaluate whether SCONE could be used as a home-based therapy to help manage orthostatic hypotension (OH) and bowel dysfunction in individuals with spinal cord injury (SCI) or multiple system atrophy (MSA).
Eligible participants will begin with baseline assessments to evaluate autonomic function and determine optimal electrode placement and stimulation intensity. This will be followed by two weeks of supervised lab-based sessions (three per week) to train participants in using the device with help from their caregiver.
Once trained, participants will continue therapy for six weeks, using the device one hour per day, three days per week, all conducted under supervision at the research center in a mock home environment. At the end of the therapy period, participants will return for two follow-up visits to repeat assessments and measure any changes.
The information gathered will help determine whether SCONE is a safe, practical, and effective option for future home-based treatment of autonomic dysfunctions in people living with SCI or MSA.
Why should you participate?
Spinal cord stimulation (SCS) has shown promise for treating autonomic dysfunctions, including OH. While epidural SCS (eSCS) has demonstrated benefits, it involves invasive procedures and other limitations. SCONE offers a non-invasive alternative with the potential for easier and safer use.
Home-based therapy is critical for improving activities of daily living and reducing the clinical burden including commute and cost for those with neurological conditions. A home-based rehabilitation provided a significant motor recovery compared to conventional therapies. tSCS is a good candidate for a home-based therapy based on its simple application, use of commercially available electrodes, non-invasiveness, and portable device size.
By participating, individuals will help advance the development of more accessible, practical therapies that may improve daily function and quality of life for those living with SCI or MSA.
You may be eligible to participate in this study if you:
A participant must meet all of the following criteria in order to be eligible for inclusion:
1. Resident of British Columbia, Canada, with active provincial medical services plan
2. Male or female, 19-70 years of age
3. Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR MSA of the parkinsonian type.
4. >1-year post injury or diagnosis, at least 6 months from any spinal surgery.
5. American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH for MSA.
6. Willing and able to comply with all clinic visits and study-related procedures.
7. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
9. Stable management of spinal cord related clinical issues (i.e., spasticity management).
10. Must provide informed consent.
11. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
- Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.You may not be eligible to participate if you:
You may not be eligible to participate if you:
A participant who meets any of the following criteria will be ineligible to participate:
1. Ventilator dependent.
2. Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
4. Intrathecal baclofen pump.
5. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
6. Presence of severe acute medical issue that in the investigator’s judgement would adversely affect the participant’s participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications [tricyclics], debilitating muscle pain, pressure sores, or unstable diabetes.
7. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
8. Takes more than 40mg of Baclofen per day
9. Severe anemia (Hgb<8 g/dl or Hgb<80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months.
10. Participant has undergone electrode implantation surgery.
Time commitment: Approximately 10 weeks with 29 study visits.
Compensation for participation: $20 CAD per visit to a maximum of $620 CAD.
This study will take place at: ICORD/Blusson Spinal Cord Centre (818 West 10th Avenue, Vancouver, BC)
For more information or to sign up to participate, please contact study coordinator Erika Escamilla by email or at (604) 675-8856
