BridgeMD
New treatment option for Spinal Cord Injuries
Official title Transcutaneous Spinal Cord Stimulation Home Study
ClinicalTrials.gov ID: NCT06838637
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70
You may be able to join if
- A participant must meet all of the following criteria in order to be eligible for inclusion:
- Resident of British Columbia, Canada with active provincial medical services plan
- Male or female, 19-70 years of age The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in...
- Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (MSA)...
- \>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
You likely can't join if
- 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...
- Intrathecal baclofen pump.
- Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive...
See the full eligibility criteria
Who can join
- A participant must meet all of the following criteria in order to be eligible for inclusion:
- Resident of British Columbia, Canada with active provincial medical services plan
- 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...
- 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.
- \>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
- 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 investigator).
- 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).
- 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...
- 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.
- Must provide informed consent.
What rules you out
- 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...
- 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.
- Participant has undergone electrode implantation surgery.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.