Spinal Cord Stimulation for Chronic Lower Back Pain

Recruiting in Palo Alto (17 mi)

Overseen by Jeannie Bailey, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Bmi > 28, Spine hardware, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new method called transcutaneous spinal cord stimulation (tSCS) for people with chronic low back pain. tSCS uses electrical currents applied through the skin to help reduce pain. The goal is to see if this non-invasive treatment can improve pain and movement without the need for surgery.

Will I have to stop taking my current medications?

The trial requires that your medication dose remains stable for at least 2 weeks before joining. If you need to change your medications, you must do so before this 2-week period.

What data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation for chronic lower back pain?

Research shows that Transcutaneous Spinal Cord Stimulation (tSCS) can improve motor function and sensorimotor recovery in individuals with spinal cord injuries by modulating spinal cord activity. This suggests that tSCS may also help with chronic lower back pain by enhancing spinal cord function and reducing pain. ^{1 2 3 4 5}

Is spinal cord stimulation safe for humans?

Spinal cord stimulation (SCS) has been shown to be generally safe for humans, with a low rate of serious adverse events. In a study with over 1,200 participants, the most common serious issue was implant site infection, occurring in less than 1% of cases. ^{2 6 7 8 9}

How is transcutaneous spinal cord stimulation (tSCS) different from other treatments for chronic lower back pain?

Transcutaneous spinal cord stimulation (tSCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, potentially improving motor function and reducing pain without surgery. Unlike traditional spinal cord stimulation, which requires surgical implantation, tSCS offers a less invasive option for modulating spinal cord activity. ^{1 2 4 10 11}

Research Team

Anastasia Keller, PhD

Principal Investigator

University of California, San Francisco

Jeannie Bailey, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals with chronic lower back pain who can get in and out of a chair on their own. They shouldn't have had any medication changes or started new ones within two weeks before joining the study. People with a BMI over 28, spinal hardware from past surgeries, epidural stimulation leads, other neuromuscular pain conditions, intolerance to electrical stimulation, or moderate/severe depression are excluded.

Inclusion Criteria

No changes in medication within 2 weeks of study enrollment

I have low back pain.

I can get in and out of a chair without help.

Exclusion Criteria

Changes in medications within 2 weeks of study enrollment

You have had a procedure involving epidural stimulation leads.

I experience muscle pain not related to my spine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation (tSCS) to assess its feasibility in improving pain scores and objective measures such as sit-to-stand biomechanics, neurophysiological, and neuroimaging outcomes.

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous Spinal Cord Stimulation (Procedure)

Trial Overview The trial is testing tSpinalStim (transcutaneous spinal cord stimulation) as a non-invasive treatment for chronic low back pain. It aims to see if this method can improve patient-reported outcomes like pain scores and objective measures such as sit-to-stand biomechanics without requiring surgical implantation.

Participant Groups

Group I: tSpinalStim Experimental Treatment 1 Intervention

Individuals in this arm will receive spinal cord stimulation

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

National Science Foundation Center for Disruptive Musculoskeletal Innovations

Collaborator

Trials

1

Recruited

50+

Findings from Research

In a pilot study involving 20 patients with idiopathic Restless Legs Syndrome (RLS) and 14 healthy subjects, transcutaneous spinal direct current stimulation (tsDCS) was shown to reduce symptoms of RLS, indicating its potential as a non-invasive treatment option.

Anodal stimulation specifically decreased spinal excitability, as measured by the H2/H1-ratio, and led to significant reductions in RLS symptoms, while sham stimulation had no effect, supporting the idea that spinal cord hyperexcitability contributes to RLS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. Heide, AC., Winkler, T., Helms, HJ., et al.[2018]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

Transcutaneous spinal Direct Current Stimulation (tsDCS) can effectively modulate interhemispheric motor connectivity, with anodal stimulation increasing interhemispheric delay and decreasing the duration of the ipsilateral Silent Period, indicating enhanced communication between brain hemispheres.

The study suggests that tsDCS could serve as a promising therapeutic tool for conditions involving impaired interhemispheric balance, offering a safe alternative for rehabilitation in patients with acute brain lesions when other non-invasive brain stimulation techniques may not be suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. Bocci, T., Caleo, M., Vannini, B., et al.[2022]

Anodal transcutaneous spinal direct current stimulation (tsDCS) significantly increased the temporal summation threshold of the nociceptive withdrawal reflex in 10 healthy subjects, indicating its potential to modulate spinal cord pain pathways.

This stimulation also led to a decrease in the perception of pain, suggesting that anodal tsDCS could be an effective non-invasive treatment for clinical pain conditions related to spinal cord activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans. Perrotta, A., Bolla, M., Anastasio, MG., et al.[2017]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

In a study involving 128 patients with chronic low back pain (LBP) and leg pain, Differential Target Multiplexed spinal cord stimulation (DTM SCS) showed a significantly higher responder rate of 80.1% compared to 51.2% for traditional SCS after 3 months, indicating its superior efficacy.

The mean reduction in LBP was also greater with DTM SCS (5.36 cm) than with traditional SCS (3.37 cm), and these improvements were maintained over a 12-month follow-up, with similar safety profiles for both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Fishman, M., Cordner, H., Justiz, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. [2022]