Spinal Stimulation for Spinal Cord Injury

(SCI Trial)

Overseen By Einat Engel-Haber, MD

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)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Biostim-5 transcutaneous spinal stimulation can help individuals with recent spinal cord injuries manage blood pressure more effectively. The researchers aim to determine if this treatment can prevent dizziness and nausea caused by blood pressure drops during movement by comparing real stimulation to a placebo-like treatment. The trial seeks participants who have experienced a spinal cord injury within the last 30 days and are experiencing symptoms such as dizziness when sitting up. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance treatment options for spinal cord injuries.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have started new cardiac medications in the past 5 days, you may not be eligible to participate.

What prior data suggests that this spinal stimulation is safe for individuals with spinal cord injury?

Research has shown that transcutaneous spinal stimulation, such as the Biostim-5 device, is generally well-tolerated. In earlier studies, adults with spinal cord injuries experienced improved strength and control with this type of stimulation. Importantly, these studies found the treatment had manageable side effects.

Another study on adults with spinal cord injuries found this stimulation method safe and practical, with no reports of serious negative effects. This suggests it is a safe option for participants. Overall, the evidence indicates that Biostim-5 transcutaneous spinal stimulation is a safe treatment for those considering joining this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Biostim-5 transcutaneous spinal stimulation is unique because it offers a non-invasive way to potentially modulate blood pressure in individuals with spinal cord injuries. Unlike standard treatments that might rely on medications to manage blood pressure, this technique uses external electrical stimulation, which could reduce dependency on drugs and their associated side effects. Researchers are excited about this method because it targets the spinal cord directly through the skin, which might improve blood pressure regulation more naturally and effectively for those affected by spinal cord injuries.

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

Research has shown that transcutaneous spinal cord stimulation (tSCS), such as the Biostim-5 used in this trial, can influence blood pressure in people with spinal cord injuries. Some participants will receive optimal stimulation during an orthostatic sit-up challenge to modulate systolic blood pressure. Studies have found that tSCS can help maintain steady blood pressure, which is crucial for those experiencing orthostatic hypotension—a condition where blood pressure drops upon standing, causing dizziness or fainting. This stimulation sends gentle electrical signals through the skin to the spine, potentially improving blood flow. Although more research is needed, early results are promising and suggest that tSCS might help maintain stable blood pressure levels. Additionally, tSCS has been shown to enhance muscle strength and control in people with spinal cord injuries. ^{1 2 3 6 7}

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 acute spinal cord injury (7-30 days post-injury) at or above the T2 level, who experience low blood pressure symptoms. They must have an AIS grade of A-C and not be on new cardiac meds within the last 5 days. Exclusions include current severe illness, pregnancy, mental incapacity to consent, cancer, ventilator dependence, history of stimulators or pacemakers/defibrillators.

Inclusion Criteria

My injury occurred between 1 to 4 weeks ago.

You have a spinal cord injury classified as AIS A, B, or C.

I experience low blood pressure or symptoms when I stand up.

Exclusion Criteria

I have not had a recent heart attack or serious heart disease.

I have cancer.

I started new heart medication within the last 5 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo orthostatic tests with optimal and sham spinal stimulation to evaluate blood pressure response and orthostatic symptoms.

2 weeks

Multiple sessions throughout the 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of blood pressure, orthostatic symptoms, and adverse effects.

2 weeks

Extension

Participants may continue to receive spinal stimulation to further assess long-term effects on blood pressure and orthostatic symptoms.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Biostim-5 transcutaneous spinal stimulation
• Orthostatic challenge

Trial Overview The study tests if transcutaneous spinal stimulation can stabilize blood pressure in acute SCI patients during orthostatic challenges (moving from lying down to sitting up). It compares 'optimal' stimulation settings against a 'sham' placebo-like treatment to see which is better at preventing drops in blood pressure.

How Is the Trial Designed?

Group I: Optimal stimulation (for a blood pressure response) Active Control 3 Interventions

Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.

Group II: Sham stimulation Placebo Group 3 Interventions

Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293838/

Cumulative Transcutaneous Spinal Stimulation with ... This intervention shows potential synergistic benefits, warranting further research to confirm efficacy and optimize therapeutic protocols.

2. 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 ...

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

Transcutaneous Cervical Spinal Cord Stimulation ... On the other side, previous studies demonstrated that tSCS is also a promising technique to improve the voluntary motor activity of the upper ...

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

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 ...

5. jneurosci.org jneurosci.org/content/40/13/2633

Cortical and Subcortical Effects of Transcutaneous Spinal ... These novel observations demonstrate that TESS influences cortical and spinal networks, having an excitatory effect at the spinal level and an inhibitory ...

6. withpower.com withpower.com/trial/phase-spinal-cord-injuries-10-2019-769de

Transcutaneous Spinal Stimulation for Spinal Cord Injury This N/A medical study run by University of Louisville is evaluating whether Biostim-5 transcutaneous spinal stimulator will have tolerable side effects ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04077346

Neuromodulation of Spinal Locomotor Circuitry to Elicit ... Studies have demonstrated, first, that after SCI, the CPG can be "accessed", reactivated, and retrained via sensory feedback arising from the muscles and joints ...