Low Frequency Soundwave Stimulation for Peripheral Neuropathy

Overseen By James T Sonnenberg, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Augusta University

Must be taking: Carboplatin, Paclitaxel

Must not be taking: Gabapentin, Duloxetine, Pregabalin

Disqualifiers: Neuropathy, Pregnancy, DVT, others

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

Compensation: Varies

Number of Visits: 21

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in preventing or reducing chemotherapy induced peripheral neuropathy (CIPN) in patients receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy. This study will also assess the improvement of CIPN in patients who have previously received carboplatin and paclitaxel therapy with persistent Grade 2 or worse neuropathy. The main questions this clinical trial aims to answer are: 1. To investigate the efficacy of SensoniQ® Treatment Station on the prevention or reduction of CIPN in gynecologic oncology patients receiving front line carboplatin and paclitaxel. 2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of existing CIPN in patients who previously received chemotherapy with platinum agent and paclitaxel for a gynecologic malignancy

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are currently prescribed gabapentin, duloxetine, or pregabalin, you cannot participate in Cohort A.

What data supports the effectiveness of the treatment SensoniQ Treatment Station for peripheral neuropathy?

Research on similar treatments, like whole body vibration therapy, has shown benefits in reducing pain and improving balance and quality of life in patients with diabetic peripheral neuropathy. Additionally, devices that use nerve stimulation have been effective in evaluating and potentially treating sensory abnormalities in neuropathy. ^{1 2 3 4 5}

Is low frequency soundwave stimulation for peripheral neuropathy safe for humans?

The available research does not directly address the safety of low frequency soundwave stimulation for peripheral neuropathy, but similar treatments like transcutaneous electrical nerve stimulation (TENS) have been studied and generally show minimal adverse effects, such as localized skin irritation or minor discomfort. ^{3 6 7 8 9}

How is the SensoniQ Treatment Station different from other treatments for peripheral neuropathy?

The SensoniQ Treatment Station uses low frequency soundwave stimulation, which is a novel approach compared to traditional treatments like medication or physical therapy. This method is unique because it targets nerve function directly through soundwaves, potentially offering a non-invasive alternative for managing symptoms of peripheral neuropathy. ^{3 4 10 11 12}

Eligibility Criteria

This trial is for adults over 18 with gynecologic cancers who are about to start or have completed carboplatin and paclitaxel chemotherapy. Participants must not be pregnant, excessively overweight, or have certain preexisting conditions like severe neuropathy or diseases that cause it.

Inclusion Criteria

My cancer diagnosis is confirmed and it affects my reproductive organs.

My first treatment for cancer includes carboplatin and paclitaxel.

I've been treated with carboplatin and paclitaxel and have ongoing severe nerve pain or damage.

Exclusion Criteria

Pregnant

I have a condition like lupus or diabetes but no nerve pain, and my blood sugar levels are controlled.

Body weight greater 195kg

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Cohort A)

Patients with newly diagnosed gynecologic cancer receive up to 8 cycles of SensoniQ treatment along with their chemotherapy

Up to 24 weeks

Weekly or every 21 days depending on regimen

Treatment (Cohort B)

Patients with persistent neuropathy receive a 30-minute SensoniQ treatment twice weekly

4 weeks

Twice weekly

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

• SensoniQ Treatment Station

Trial Overview The SensoniQ Treatment Station's ability to prevent or reduce chemotherapy-induced peripheral neuropathy in patients receiving frontline chemo for gynecologic malignancies is being tested. It also examines improvement in those with existing CIPN from such treatments.

Participant Groups

Group I: Cohort B Experimental Treatment 1 Intervention

In this arm, gynecologic cancer patients with persistent neuropathy following treatment with platinum agent and paclitaxel will receive a 30 minute SensoniQ treatment twice weekly for 4 weeks.

Group II: Cohort A Experimental Treatment 1 Intervention

In this arm, patients with newly diagnosed gynecologic cancer starting chemotherapy treatment with carboplatin and paclitaxel will receive up to 8 cycles of SensoniQ treatment along with their chemotherapy (weekly or every 21 days depending on the regimen).

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Findings from Research

In a pilot study involving four patients with chronic neuropathic pain, computer tomographic (CT) techniques were successfully used to improve the positioning of peripheral nerve stimulator (PNS) leads, enhancing treatment effectiveness.

The study demonstrated that CT scans can reliably detect the position of implanted nerve electrodes in relation to neurovascular structures, suggesting they are superior to standard X-rays for monitoring lead placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation: lead position monitoring by reconstruction CT angiography--a technical report. Klase, D., Bischof, A., Haendler, G., et al.[2016]

Ultrasound-guided placement of peripheral nerve stimulation electrodes in cadaver specimens showed no gross nerve damage and allowed for precise positioning near the targeted nerves, indicating a safe method for potential clinical use.

Out of the three electrodes placed, only one showed significant migration after 21 hours of simulated activity, suggesting that the anchoring technology used may effectively minimize electrode movement during normal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes and anchoring during simulated movement: part two, upper extremity. Huntoon, MA., Hoelzer, BC., Burgher, AH., et al.[2019]

A new device that measures current perception thresholds (CPTs) shows that normal individuals have higher thresholds on the toe compared to the face, and these thresholds are influenced by age and sex.

In patients with peripheral neuropathy, particularly those with diabetic neuropathy, the device detected significantly elevated CPTs on hands, feet, and even the face, indicating its potential as a sensitive screening tool for sensory nerve issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constant current sine wave transcutaneous nerve stimulation for the evaluation of peripheral neuropathy. Katims, JJ., Naviasky, EH., Rendell, MS., et al.[2004]

Whole body vibration (WBV) therapy significantly improves pain, neuropathy disability, balance, and quality of life in patients with painful diabetic peripheral neuropathy (PDPN) after six weeks of treatment, as shown in a study of 26 participants.

The study found that WBV therapy led to notable improvements in various measures, including pain ratings and vibration perception, compared to a control group receiving standard care, highlighting its potential as an effective adjunct therapy for PDPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. Jamal, A., Ahmad, I., Ahamed, N., et al.[2022]

A 52-year-old patient with severe postherpetic neuralgia experienced a significant reduction in pain intensity from 8/10 to 1/10 after receiving a high-frequency peripheral nerve stimulation implant, demonstrating the efficacy of this technique over a 9-month follow-up period.

The use of high-frequency stimulation (100-1200 Hz) provided effective pain relief without the side effects of paresthesia, indicating a safer and more comfortable alternative to traditional low-frequency stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel High-Frequency Peripheral Nerve Stimulator Treatment of Refractory Postherpetic Neuralgia: A Brief Technical Note. Lerman, IR., Chen, JL., Hiller, D., et al.[2022]

The Neuro-Stim System™ devices, used for pain relief through a minimally invasive procedure, have been deemed low-risk by various regulatory bodies, indicating a favorable safety profile.

In a study monitoring 1,207 devices and over 19,000 punctures, the incidence of adverse effects such as bleeding, dermatitis, and infections was quantified, providing valuable data on the safety of this neuromodulation technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. Roberts, A., Sithole, A., Sedghi, M., et al.[2020]

In a study involving 180 healthy volunteers, the combination of transcutaneous electrical neural stimulation (TENS) and heat significantly increased pain thresholds, making pain feel less intense and unpleasant.

This suggests that using multiple physical treatments together, like TENS and heat, can be more effective for pain relief than using each treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of TENS, Heat, and Cold on the Pain Thresholds Induced by Mechanical Pressure in Healthy Volunteers. Solomon, J., Shebshacvich, V., Adler, R., et al.[2022]

In a study involving 19 patients with mild-to-moderate diabetic neuropathy, the TENS device 'Salutaris' significantly reduced symptoms after 6 weeks (-42%) and 12 weeks (-32%) compared to baseline, demonstrating its efficacy as a treatment option.

The TENS treatment led to notable improvements in specific symptoms such as numbness, lancinating pain, and allodynia, while the placebo group showed no significant changes, highlighting the device's potential as a non-pharmacological therapy for painful diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of low frequency transcutaneous electrical nerve stimulation on symptomatic diabetic neuropathy using the new Salutaris device. Forst, T., Nguyen, M., Forst, S., et al.[2015]

In a study involving 26 adults, exposure to sinusoidal magnetic fields at frequencies from 2 to 183 kHz showed that the likelihood of experiencing unpleasant peripheral nerve stimulation (PNS) significantly decreased at frequencies of 101 kHz and above, indicating a safer range for MRI applications.

The findings suggest that using higher frequency magnetic fields could enhance MRI techniques, particularly in dynamic imaging scenarios like cardiac studies, while minimizing discomfort from nerve stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing the oscillation frequency of strong magnetic fields above 101 kHz significantly raises peripheral nerve excitation thresholds. Weinberg, IN., Stepanov, PY., Fricke, ST., et al.[2021]

The Neurometer effectively distinguishes between different types of nerve fiber damage in patients with diabetic neuropathy by measuring current perception thresholds at various frequencies, showing significant differences compared to non-diabetic controls.

While the Neurometer demonstrates neuroselectivity, its reproducibility is lower in neuropathic patients compared to controls, indicating variability in results, similar to traditional sensory tests like vibration and thermal perception thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of the Neurometer in assessing diabetic neuropathy by measurement of the current perception threshold. Pitei, DL., Watkins, PJ., Stevens, MJ., et al.[2022]

A case study of a 53-year-old woman with chronic lower extremity neuropathic pain showed that a design-specific peripheral nerve stimulation (PNS) device provided significant pain relief and improved functionality for two years after implantation.

This case highlights the effectiveness of modern PNS technology, suggesting it may be a preferable option over spinal cord stimulation for patients with isolated extremity pain, particularly those with spinal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

Using an electromagnetic vibrator to measure vibration thresholds in patients with polyneuropathy showed that expressing thresholds in terms of amplitude of stimulator movement is more effective than using applied voltage, leading to better discrimination at all tested sites.

Reference values for vibration perception thresholds were established from 110 healthy males aged 10 to 74, revealing a strong correlation with age, and suggesting that measuring the perception threshold alone may be adequate for clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardised method of determining vibratory perception thresholds for diagnosis and screening in neurological investigation. Goldberg, JM., Lindblom, U.[2022]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation: lead position monitoring by reconstruction CT angiography--a technical report. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes and anchoring during simulated movement: part two, upper extremity. [2019]

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

Constant current sine wave transcutaneous nerve stimulation for the evaluation of peripheral neuropathy. [2004]

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

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. [2022]

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

Novel High-Frequency Peripheral Nerve Stimulator Treatment of Refractory Postherpetic Neuralgia: A Brief Technical Note. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study. [2020]

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

The Effects of TENS, Heat, and Cold on the Pain Thresholds Induced by Mechanical Pressure in Healthy Volunteers. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Impact of low frequency transcutaneous electrical nerve stimulation on symptomatic diabetic neuropathy using the new Salutaris device. [2015]

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

Increasing the oscillation frequency of strong magnetic fields above 101 kHz significantly raises peripheral nerve excitation thresholds. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The value of the Neurometer in assessing diabetic neuropathy by measurement of the current perception threshold. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Standardised method of determining vibratory perception thresholds for diagnosis and screening in neurological investigation. [2022]