Testing Spinal COrd NEuromodulation ("SCONE") for spinal cord injuries

Inclusion

• +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) ProtocolProtocolThe detailed plan a study must follow.Read more → Version 1.0, December 8, 2023 Page 6 of 23
• +A participant must meet all of the following criteria in order to be eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
• +Resident of British Columbia, Canada with active provincial medical services plan
• +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.
• +American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.
• +Willing and able to comply with all clinic visits and study-related procedures.
• +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →).
• +No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
• +Stable management of spinal cord related clinical issues (i.e., spasticity management).
• +Must provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• +EXCLUSION CRITERIAExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +A participant who meets any of the following criteria will be ineligible to participate:
• +Ventilator dependent.
• +Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
• +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.
• +Intrathecal baclofen pump.
• +Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive renal stones.
• +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.
• +Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
• +Takes more than 40mg of Baclofen per day.
• +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.
• +Participant is a member of the investigational team or his/her immediate family.
• +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 visitBaselineYour starting measurements, taken before treatment begins.Read more →.
• +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.
• +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.
• +\>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
• +Participant has undergone electrode implantation surgery.