Pulse Width Modulation for Spinal Conditions

Overseen By Beverly Allen, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Neonates, Minors, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Pulse-Width Modulation for spinal conditions?

Research on spinal cord stimulation (SCS), which is similar to pulse-width modulation, shows that SCS can provide significant pain relief and improve quality of life for patients with failed back surgery syndrome, as seen in a study where patients experienced sustained benefits over 24 months. ^{1 2 3 4 5}

How is Pulse Width Modulation treatment different from other treatments for spinal conditions?

Pulse Width Modulation in spinal cord stimulation is unique because it allows for adjustable pulse widths, which can enhance the precision of nerve activation and potentially improve pain management by targeting specific nerve fibers more effectively than traditional fixed-parameter treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.

Research Team

Linton T Evans, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for patients scheduled for spine surgery involving pedicle screw placement and intraoperative neuromonitoring, specifically those with conditions like spinal fusion or stenosis.

Inclusion Criteria

I am scheduled for surgery that involves placing screws in my spine and monitoring nerve function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

In vivo electrical stimulation of pedicle screws with varying pulse-width settings to record CMAP response

1 day

1 visit (in-person, operating room)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Pulse-Width Modulation

Trial Overview The study is testing pulse-width modulation during stimulation of pedicle screws in spine surgeries. It aims to find out the response thresholds at different settings without collecting further data.

Participant Groups

Group I: Pedicle Screw Stimulation Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Findings from Research

The EVIDENCE study is a multicenter randomized controlled trial designed to compare the effectiveness and cost-effectiveness of spinal cord stimulation (SCS) with rechargeable pulse generators against re-operation in patients suffering from failed back surgery syndrome, involving a sample size of 132 subjects.

The primary outcomes will assess the proportion of patients achieving at least 50% leg pain relief at 6 and 24 months, providing crucial data on the long-term efficacy of SCS compared to traditional surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study). North, RB., Kumar, K., Wallace, MS., et al.[2022]

SMART spinal implants, which incorporate data-logging sensors, have been developed to enhance the safety and efficacy of traditional orthopedic devices, with 18 studies analyzing their performance.

These implants primarily utilize strain gauges to monitor loading, which helps in detecting potential failures and assessing the healing process, although current studies have involved small sample sizes of no more than 20 patients per study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'SMART' implantable devices for spinal implants: a systematic review on current and future trends. Kim, SJ., Wang, T., Pelletier, MH., et al.[2022]

In a study of 100 patients with failed back surgery syndrome, those receiving spinal cord stimulation (SCS) alongside conventional medical management reported significantly better leg pain relief, quality of life, and functional capacity at 24 months compared to those receiving conventional management alone.

At the 24-month mark, 37% of patients who continued SCS achieved over 50% leg pain relief, compared to only 2% in the conventional management group, highlighting the long-term efficacy of SCS in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Kumar, K., Taylor, RS., Jacques, L., et al.[2022]

The battery-operated patient-moving device has been demonstrated to be both safe and effective for transferring patients with vertebral and spinal cord injuries.

This device provides a practical solution for healthcare providers, ensuring the safe movement of patients while minimizing the risk of further injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the mobilizer in the care of acute spinal injuries. Brackett, TO.[2019]

Position-related changes in spinal cord stimulation can lead to fluctuations in paresthesia perception due to the distance between electrodes and the spinal cord, affecting the effectiveness of pain relief for patients.

A new spinal cord stimulation system using accelerometer technology is being developed to automatically adjust stimulation based on patient position, which may improve pain management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient experience with spinal cord stimulation: implications of position-related changes in neurostimulation. Ross, E., Abejón, D.[2022]

In a study involving patients with chronic low back and leg pain using spinal cord stimulation (SCS), varying the pulse width (PW) settings led to significant improvements in paresthesia-pain overlap for some patients, with an average increase of 56%.

The findings suggest that patients can benefit from personalized PW programming, as 7 out of 19 patients chose new settings that enhanced their pain relief experience, indicating that PW adjustments can effectively 'steer' paresthesia coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse width programming in spinal cord stimulation: a clinical study. Yearwood, TL., Hershey, B., Bradley, K., et al.[2019]

The wireless Freedom Spinal Cord Stimulator (WSCS) significantly reduced chronic back and leg pain in patients with failed back surgery syndrome (FBSS), with a 77% reduction in pain for high-frequency (HF) stimulation and 64% for low-frequency (LF) stimulation after six months.

Both HF and LF stimulation showed substantial improvements in various quality of life measures, indicating that the WSCS is an effective treatment option for chronic pain associated with FBSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study. Bolash, R., Creamer, M., Rauck, R., et al.[2020]

In a study of 142 patients undergoing lumbar spinal fusion, the use of pulsed electromagnetic field (PEMF) stimulation as an adjunct therapy resulted in an impressive 88% fusion success rate at 12 months, even among patients with risk factors for complications.

Patients reported significant improvements in pain, function, and quality of life after PEMF treatment, indicating that it is a safe and effective option to enhance recovery from spinal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis. Weinstein, MA., Beaumont, A., Campbell, P., et al.[2023]

In a study examining spinal cord stimulation parameters, pulse width (Pw) significantly influenced stimulation thresholds, but did not affect the coverage or quality of paresthesia experienced by patients.

Frequency (F) adjustments were found to be crucial for enhancing the coverage of painful areas and improving the quality of paresthesia perception, suggesting that frequency management is key for effective pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electric parameters optimization in spinal cord stimulation. Study in conventional nonrechargeable systems. Abejón, D., Cameron, T., Feler, C., et al.[2022]

A mathematical model of spinal cord stimulation (SCS) suggests that varying pulse width (PW) can enhance the activation of specific nerve fibers, particularly medial dorsal column fibers, which may improve therapeutic outcomes.

The model's predictions were supported by clinical data, indicating that adjusting PW programming can effectively 'steer' nerve fiber recruitment, highlighting its potential for optimizing SCS treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Lee, D., Hershey, B., Bradley, K., et al.[2021]

References

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

Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study). [2022]

2. China pubmed.ncbi.nlm.nih.gov

'SMART' implantable devices for spinal implants: a systematic review on current and future trends. [2022]

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

The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. [2022]

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

Use of the mobilizer in the care of acute spinal injuries. [2019]

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

Improving patient experience with spinal cord stimulation: implications of position-related changes in neurostimulation. [2022]

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

Pulse width programming in spinal cord stimulation: a clinical study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis. [2023]

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

Electric parameters optimization in spinal cord stimulation. Study in conventional nonrechargeable systems. [2022]

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

Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. [2021]