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New treatment option for Spinal Cord Injuries
Official title Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
ClinicalTrials.gov ID: NCT06313515
What this study is testing
- What it's testing
- Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Are between 21-65 years of age.
- Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
- Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery.
- American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
- Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities.
You likely can't join if
- Have autoimmune etiology of spinal cord dysfunction/injury
- Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.
- Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Are ventilator dependent.
- Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
See the full eligibility criteria
Who can join
- Are between 21-65 years of age.
- Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
- Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery.
- American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
- Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities.
- Cleared for strenuous exercise with arm bike by a primary physician of the subject (the clearance for intensive training with arm bike is obtained verbally or through a written form by a primary physician.)
- 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).
- Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
- Are with 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: -----Women of childbearing potential must agree to use adequate contraception...
- 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.
- Are volunteering to be involved in this study.
- Has adequate social support to be able to participate in training and assessment sessions, up to 3 sessions per week, for the duration of up to 6 months within the study period.
- Must provide informed consent.
What rules you out
- Have autoimmune etiology of spinal cord dysfunction/injury
- Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.
- Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Are ventilator dependent.
- Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
- Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
- Have Intrathecal baclofen pump.
- Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
- Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active...
- Have pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators.
- Take more than 40 mg of Baclofen per day
- Have 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.
- Are a member of the investigational team or his/her immediate family.
- Have undergone electrode implantation surgery.
- Have signs of lower motor neuron impairment (i.e., concomitant conus medullaris/cauda equina injury).
- Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
- Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
- Have a history of seizures.
- Have chronic headaches or migraines.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
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, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. 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.