Spinal Cord Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether non-invasive spinal cord stimulation, specifically Spinal Cord Transcutaneous Stimulation, can help regulate blood pressure in individuals with chronic spinal cord injuries. Researchers aim to determine if stimulating specific spinal cord areas can improve blood pressure control and affect the enzymes involved in its regulation. Participants will receive stimulation through electrodes placed on their skin. This trial suits individuals with a stable spinal cord injury for over a year who experience low blood pressure symptoms. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatments for blood pressure issues related to spinal cord injuries.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this spinal cord stimulation technique is safe for individuals with spinal cord injury?
Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe for people with spinal cord injuries. In one study, 88.5% of sessions had no negative effects. Some minor issues, such as changes in heart rate or blood pressure, have been reported but remain uncommon. Another study confirmed the safety of tSCS, especially when combined with rehabilitation, and found it improved muscle strength without serious side effects.
For the CV-scTS 1 treatment, evidence suggests that tSCS is safe and can enhance leg function and walking speed, with few safety concerns. The Resp-scTS treatment also appears safe. Studies have demonstrated that using tSCS in the mid-back area is safe and practical, even for children.
Overall, the available data suggest these treatments are well-tolerated and have a good safety record.12345Why are researchers excited about this trial's treatments?
Researchers are excited about spinal cord transcutaneous stimulation (scTS) for spinal cord injury because it offers a non-invasive approach to improving blood pressure regulation and respiratory function, which are major challenges for patients with spinal cord injuries. Unlike standard care options like medication and physical therapy, scTS directly targets specific spinal cord levels using electrical stimulation to enhance autonomic functions. This method allows for precise mapping and adjustment of stimulation parameters, potentially leading to personalized treatment plans that could significantly improve quality of life for individuals with spinal cord injuries. With its innovative mechanism of action, scTS could represent a breakthrough in how these injuries are managed.
What evidence suggests that this trial's spinal cord stimulation treatments could be effective for blood pressure regulation in spinal cord injury?
This trial will evaluate spinal cord transcutaneous stimulation (scTS) for individuals with spinal cord injuries. Participants will receive scTS at various spinal levels in different trial arms. Studies have shown that scTS can stabilize blood pressure, especially when applied to the lower and mid-back areas, aiding heart control and blood pressure improvement. Additionally, scTS applied to the upper back has improved breathing and muscle strength. While more research is needed, these findings suggest that spinal cord stimulation may help manage blood pressure and support breathing health in individuals with spinal cord injuries.678910
Who Is on the Research Team?
Alexander Ovechkin
Principal Investigator
University of Louisville
Are You a Good Fit for This Trial?
This trial is for adults (18+) with a spinal cord injury above the T1 level that happened at least a year ago, who have stable health and low blood pressure symptoms. Participants must be able to give consent, understand instructions, and have normal kidney function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-intervention
Pre-intervention assessments including randomization and mapping
Treatment
Participants receive spinal cord stimulation for blood pressure regulation over 80 sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Spinal Cord Transcutaneous Stimulation
Trial Overview
Researchers are testing non-invasive electrical stimulation of the spinal cord using electrodes placed on the skin to see if it helps regulate blood pressure in people with chronic spinal cord injuries. Different electrode placements will be compared.
How Is the Trial Designed?
3
Treatment groups
Active Control
The participants in this arm will receive spinal cord stimulation at the lumbosacral level (L1 to S1 spinal cord levels) targeted for blood pressure regulation. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.
The participants in this arm will receive spinal cord stimulation at the thoracolumbar level (T10 to L1 spinal cord levels) targeted for blood pressure regulation. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.
Qualifying participants of NCT06019949 (IRB #23.0570) randomized to the respiratory stimulation alone intervention group (Resp-scTS) will be invited to participate in this study to collect additional outcome measures. Overlapping assessments will be shared between the two studies. Participants in this arm will receive spinal cord stimulation at the thoracic level (T1 to T9 spinal cord levels) targeted for respiratory function. There will be mapping sessions where stimulation will be provided to assess the impact on functional outcomes and to refine stimulation parameters for training. Using multi-variant combinations of electrode locations and different electrical configurations, the stimulation will be delivered with frequency of up to 100 Hz, with incrementally increased intensity up to 200mA. During stimulation interventions, 5 mA-sub-motor threshold intensity with mapping-identified frequency, pulse width, and intensity will be delivered during interventional bouts.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
Kentucky Spinal Cord and Head Injury Research Board
Collaborator
Citations
Safety, feasibility, and efficacy of transcutaneous spinal ...
Spinal cord stimulation (SCS) is a form of therapy that may improve blood pressure in patients with SCI, thus allowing for better participation in prescribed ...
Transcutaneous Stimulation in Spinal Cord Injury
Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, ...
Cardiovascular safety of transcutaneous spinal cord ...
This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.
Short-Term Repeated Transcutaneous Spinal Cord ...
While spinal cord transcutaneous stimulation (scTS) has shown immediate effects on blood pressure regulation, its long-term effects remain largely unexplored.
Transcutaneous Spinal Cord Stimulation to Stabilize Seated ...
Secondary outcomes recorded include 1) symptoms related to autonomic dysreflexia and orthostatic hypotension, 2) Likert pain scale, and 3) skin appearance after ...
Effectiveness of Transcutaneous Spinal Cord Stimulation for ...
This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, or other ...
Transcutaneous Spinal Cord Stimulation to Promote ...
The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared ...
Safety and Feasibility of Cervical and Thoracic ...
In adults with cervical spinal cord injury (SCI), transcutaneous spinal stimulation (scTS) has improved upper extremity strength and control. This novel ...
Effectiveness of transcutaneous spinal cord stimulation for ...
Current evidence suggests tSCS may improve lower limb motor function and walking speed in SCI, with a favorable safety profile. However, the evidence base has ...
Transcutaneous spinal cord stimulation plus locomotor ...
The primary outcome was walking ability (WISCI-II) with allocated stimulation at 12 weeks. A predefined between-group difference of 2 points on the WISCI-II was ...
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