BridgeMD
New treatment option for Spinal Cord Injuries
Official title Spinal Cord Stimulation and Training
ClinicalTrials.gov ID: NCT05472584
What this study is testing
- What it's testing
- This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Healthy Volunteers
- Age between 16 and 65 years old
- Healthy people with no major comorbidities of any organ system
You likely can't join if
- Healthy Volunteers
- people younger than 16 or older than 65 years old
- people not providing consent or not able to consent
- people with any acute or chronic pain condition
- people with any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study period
See the full eligibility criteria
- Healthy Volunteers
- Age between 16 and 65 years old
- Healthy people with no major comorbidities of any organ system
- Healthy Volunteers
- people younger than 16 or older than 65 years old
- people not providing consent or not able to consent
- people with any acute or chronic pain condition
- people with any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study period
- Use of caffeine with 3 hours of study appointment Inclusion criteria: Participants with spinal cord injury (SCI)
- Age between 16-65 years old
- Traumatic SCI C4-T9 level, incomplete (ASIA C or D)
- at least 1 year post injury
- Stable medical condition
- difficulty independently performing leg movements in routine activities
- able to follow simple commands
- able to speak and respond to questions Exclusion criteria: Participants with spinal cord injury (SCI)
- people younger than 16 or older than 65 years old
- Not willing or able to provide consent
- Any acute or chronic pain condition
- Any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study appointment
- Use of caffeine with 3 hours of study appointment
- Presence of tremors, spasms and other significant involuntary movements
- Etiology of SCI other than trauma
- Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
- History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for...
- Severe joint contractures disabling or restricting lower limb movements.
- Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
- Depression, anxiety, or cognitive impairment
- Deficit of visuospatial orientation
- Sitting tolerance less than 1 hour
- Severe hearing or visual deficiency
- Miss more than 3 appointments without notification
- Unable to comply with any of the procedures in the protocol
- Botulinum toxin injection in lower extremity muscles in the prior six months
- Any passive implants (osteosynthesis material, metallic plates or screws) below T9.
- Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
- History of alcoholism or another drug abuse
- Pregnancy (or possible pregnancy)
- Having an Intrathecal Baclofen Therapy Pump (ITB pump)
- History of epilepsy
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, 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, 16 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, 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.