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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different pulse-width settings during stimulation of pedicle screws (a type of spinal hardware) affect the body. The goal is to understand response thresholds, which can help improve spinal surgery techniques. Individuals scheduled for spinal surgery involving pedicle screws and monitoring during the operation might be suitable candidates for this trial. This phase collects no additional data beyond the response to pulse-width modulation, a method of electrical stimulation.

As an unphased trial, this study offers a unique opportunity to contribute to advancements in spinal surgery techniques.

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 prior data suggests that this pulse-width modulation technique is safe for spinal conditions?

Research shows that using electrical pulses in spinal cord stimulation is generally safe. Studies have found that this method, which involves sending small electrical signals to the spine, is well-tolerated by most patients. For example, one study reported that many patients experienced significant pain relief without major side effects. Another study demonstrated that non-invasive spinal cord stimulation was safe and effective for improving arm and hand function in people with spinal cord injuries. Although these studies don't specifically focus on changing the pulse width, they suggest that similar treatments are usually safe for most people.

This trial examines how changing the pulse width affects the spine's response. Since the trial is in its early stages, the main goal is to understand the basic effects and gather initial data. While detailed safety information might not be available yet, past research indicates that using electrical stimulation is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pulse-Width Modulation for spinal conditions because it's a novel technique that uses electrical stimulation in a highly controlled manner. Unlike traditional treatments such as pain medication or surgical interventions, this method aims to modulate nerve activity directly. By precisely adjusting the electrical pulses, it holds the potential to more effectively manage pain and improve spinal function, potentially reducing the need for invasive surgeries and long-term medication use.

What evidence suggests that pulse-width modulation is effective for spinal conditions?

Research has shown that pulse-width modulation (PWM) in spinal cord stimulation can improve treatment outcomes. In this trial, participants in the Pedicle Screw Stimulation Arm will receive treatment involving PWM. Similar methods, such as time-dynamic pulse modulation, have shown promise for conditions like Parkinson's Disease. These techniques can provide longer-lasting pain relief, as tests have found they reduce pain without quickly losing effect. Additionally, pulse modulation in spinal treatments has aided in accurately placing spinal screws, potentially leading to more precise treatments. While current research supports its potential, more data is needed to fully understand its effectiveness for spinal conditions. ^{2 6 7 8 9}

Who Is on the Research Team?

Linton T Evans, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867969/

Exploratory evaluation of spinal cord stimulation with dynamic ... Deep brain stimulation using temporally non-regular pulses has been shown to improve outcomes of neuromodulation treatment of movement disorders ...

2. nature.com nature.com/articles/s41598-020-77212-w

Time-dynamic pulse modulation of spinal cord stimulation ... TDPs have shown promising clinical outcomes for movement disorders such as Parkinson's Disease. Developed using a biophysical model of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014672/

Spinal cord stimulation using time-dynamic pulses ... Although TDPs and tonic stimulation comparably mitigated allodynia, TDPs exhibited slower rate of wash-out, suggesting longer-lasting analgesic effects.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925001849

Preclinical Insights Into the Effects of Frequency and Pulse ... High-frequency spinal cord stimulation (SCS) at 1000 Hz was shown to reduce evoked compound action potential (ECAP) amplitude, likely owing to asynchronous ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06120231?keyword=%22Spinal%22

San Mateo Clinical Trial Pulse-Width Modulation Pulse-Width Modulation ... In vivo electrical stimulation of pedicle screws is a well-documented modality for evaluating potential breach of the pedicle wall.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8184296/

Sustained Long-Term Outcomes With Closed-Loop Spinal ... The majority of patients experienced more than 80% pain relief with stable SC activation, as measured by ECAP amplitude at 12 mo, providing evidence for the ...

8. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715923007146

Cardiovascular Effects of Spinal Cord Stimulation Spinal cord stimulation (SCS) has been reported to modulate blood pressure (BP), heart rate (HR), and HR variability (HRV).