Transcutaneous Spinal Cord Stimulation Home Study

Launched by MICHAEL BERGER · Feb 17, 2025

Keywords

ClinConnect Summary

The Transcutaneous Spinal Cord Stimulation Home Study is a clinical trial designed to explore a new, non-invasive therapy called SCONE for individuals with spinal cord injuries or multiple system atrophy. This study aims to find out if this therapy can safely help manage problems like low blood pressure when standing (orthostatic hypotension) and bowel issues. Participants will undergo a total of about 10 weeks of involvement, which includes initial visits to the study center for evaluations, a two-week treatment phase at the center with frequent visits, and then a six-week period where they will continue treatment at home for one hour, twice a day.

To be eligible for this trial, participants must be between 19 and 70 years old, live in British Columbia, Canada, and have a chronic spinal cord injury or specific type of multiple system atrophy. They should also be at least a year post-injury or diagnosis and stable in their overall health. Throughout the study, participants will be closely monitored to ensure their safety and to evaluate how well the therapy works. It's important for anyone interested to be aware of the inclusion and exclusion criteria, which detail specific health conditions and situations that may prevent participation.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• * 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 The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in individuals with severe autonomic dysfunctions (H23-00192) Protocol Version 1.0, December 8, 2023 Page 6 of 23
• • 3. Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (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 (Orthostatic Hypotension) 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. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
• • 10.1. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
• • 10.2. 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.
• • 11. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
• • 12. Must provide informed consent.
• • EXCLUSION CRITERIA
• * 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 spinal cord injury (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 is a member of the investigational team or his/her immediate family.
• • 11. Participant has undergone electrode implantation surgery.