Transcutaneous Spinal Stimulation for Blood Pressure Control in Spinal Cord Injury

(SCI Trial)

Recruiting at 1 trial location

Overseen By Gail F Forrest, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Current illness, Ventilator-dependent, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Biostim-5 transcutaneous spinal stimulator to determine its effectiveness in controlling blood pressure for individuals with long-term spinal cord injuries, particularly those experiencing sudden drops in blood pressure upon standing. Researchers aim to identify which spinal areas respond best to stimulation for stabilizing blood pressure and to assess whether repeated use of the device enhances results over time. Ideal candidates for this trial include individuals with a spinal cord injury at or above the T6 level who experience significant drops in blood pressure when moving to a sitting position. Participants will lie on a tilting table while researchers monitor their blood pressure, both with and without stimulation. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could improve the quality of life for those with spinal cord injuries.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this transcutaneous spinal stimulation is safe for blood pressure control in spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation is generally safe for people with spinal cord injuries. This method sends small electrical currents through the skin to the spine and is usually well-tolerated. For instance, one study found that this technique improved hand movement in children with spinal cord injuries without causing serious side effects. Another study demonstrated that it helped the breathing muscles in people with spinal cord injuries, again without major problems.

These results suggest that the Biostim-5 transcutaneous spinal stimulator, used in this trial, is likely safe for stabilizing blood pressure. However, as with any medical procedure, monitoring each participant's response during the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for managing blood pressure in individuals with spinal cord injury, which often rely on medications like midodrine or fludrocortisone, the Biostim-5 transcutaneous spinal stimulator offers a non-pharmacological approach. This device is unique because it applies electrical stimulation directly to the skin over the spine, targeting specific spinal sites to regulate blood pressure. This method not only avoids the potential side effects of drugs but also allows for precise, customizable treatment tailored to each individual's needs. Researchers are excited about this innovative technique because it opens up new possibilities for improving the quality of life for people with spinal cord injuries by offering a potentially safer and more effective way to manage blood pressure.

What evidence suggests that transcutaneous spinal stimulation is effective for blood pressure control in spinal cord injury?

Research has shown that spinal cord transcutaneous stimulation (scTS), which participants in this trial will receive, can help maintain steady blood pressure in people with spinal cord injuries. Studies have found that scTS targets the part of the spine that controls blood pressure. This method appears promising for treating issues like orthostatic hypotension, where blood pressure drops upon standing. Early results suggest that multiple stimulation sessions might improve blood pressure stability over time. Overall, scTS is emerging as a hopeful approach to managing blood pressure issues in those with spinal cord injuries. ^{4 6 7 8 9}

Who Is on the Research Team?

Gail F Forrest, Phd

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with chronic spinal cord injury (SCI) who've had it for at least 6 months, have an injury level at or above T6, and experience low blood pressure symptoms. They must be able to consent and not be pregnant, ventilator-dependent, or have certain heart conditions or other medical devices implanted.

Inclusion Criteria

You have a spinal cord injury classified as AIS A, B, C, or D according to the ASIA Impairment Scale.

I have had a spinal cord injury for at least 6 months.

My spinal cord injury is at or above the T6 level.

Exclusion Criteria

Do you have a baclofen pump?

You rely on a ventilator to breathe.

You have had a device implanted in your brain, spine, or nerves.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including orthostatic tests and neurophysiological mapping

3 days

3 visits (in-person)

Stimulation Mapping

Five days of stimulation mapping to locate optimal spinal sites for blood pressure response

5 days

5 visits (in-person)

Training

Two-week training period with repeated exposure to stimulation

2 weeks

6 visits (in-person)

Testing

Testing with stimulation applied during orthostatic provocation

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biostim-5 transcutaneous spinal stimulator

Trial Overview The study tests if a Biostim-5 transcutaneous spinal stimulator can stabilize blood pressure in SCI patients during tilt-table tests. It explores the best stimulation sites and parameters to normalize blood pressure when changing positions from lying down to upright.

How Is the Trial Designed?

Group I: Participants with a chronic SCI (≥ 6 months after injury) Experimental Treatment 2 Interventions

Participants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation)

Biostim-5 transcutaneous spinal stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Biostim-5 transcutaneous spinal stimulator for:

• Spinal cord injury rehabilitation
• Upper limb function improvement

Approved in European Union as Transcutaneous Spinal Cord Stimulation (tSCS) for:

• Spinal cord injury rehabilitation
• Pain relief
• Motor function improvement

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39391052/

Neuromodulation in Spinal Cord Injury Using ... Spinal cord transcutaneous stimulation (scTS) offers a promising approach to enhance cardiovascular regulation in individuals with a high-level ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38156073/

Spinal Cord Stimulation to Stabilize Blood Pressure: Protocol tSCS is an emerging therapeutic strategy to target spinal autonomic circuitry to normalize and stabilize blood pressure (BP) in hypotensive persons living with ...

3. mdpi.com mdpi.com/2227-9059/11/2/589

Cervical SCI Rehab: Spinal Cord Stim & Robotic Exoskeleton On the other side, previous studies demonstrated that tSCS is also a promising technique to improve the voluntary motor activity of the upper ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05731986

Spinal Cord Transcutaneous Stimulation Effect on Blood ... The objective of this study is to investigate the effect of spinal cord transcutaneous stimulation (scTS) on BP in individuals with an acute/sub-acute SCI (7-30 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2542454823000644

Spinal Cord Neuromodulation for Paralysis: Proof of Concept Results report a significant difference in the effect of tSCS and EES on the recovery of neurologic functions and support consecutive tSCS and EES applications ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452666/

Transcutaneous Spinal Cord Stimulation Improves ... Transcutaneous spinal cord stimulation improves respiratory muscle strength and function in subjects with cervical spinal cord injury.

7. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00648-7/fulltext

Safety and Feasibility of Cervical and Thoracic ... Safety and feasibility of cervical and thoracic transcutaneous spinal cord stimulation to improve hand motor function in children with chronic spinal cord ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715923006487

Safety and Feasibility of Cervical and Thoracic ... We indicated that short-term application of scTS via two cervical and one thoracic site is safe and feasible in children with SCI and resulted in immediate ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469035/

Non-Invasive Cervical Spinal Stimulation and Respiratory ... Recent evidence suggests that transcutaneous electrical spinal cord stimulation (tSCS) may enhance motor strength and promote functional ...