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New treatment option for Spinal Cord Injuries
Official title Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
ClinicalTrials.gov ID: NCT06540859
What this study is testing
- What it's testing
- This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, admitted to inpatient rehabilitation facilities (IRFs) or after discharged from IRFs.
- 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.
- SCI (non-progressive) at or above the T6 spinal segment.
- Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
- American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
- Have stable medical condition that would permit participation in 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, 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...
See the full eligibility criteria
- Are between 21-65 years of age.
- SCI (non-progressive) at or above the T6 spinal segment.
- Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
- American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
- Have stable medical condition that would permit participation in testing activities.
- Willing and able to comply with all clinic visits and study-related procedures.
- Able to understand and complete study-related questionnaires in English.
- Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
- Are not currently pregnant or not intending to become pregnant during participation in this study.
- Are volunteering to be involved in this study.
- Must provide informed consent.
- Have autoimmune etiology of spinal cord dysfunction/injury
- Have history of additional neurologic disease, such as stroke, MS, 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, pressure...
- 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.
- Are a member of the investigational team or his/her immediate family.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.