Scrambler Therapy for Neuropathic Pain

(ST-CBS Trial)

Overseen By Maria Schmidt, CRNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Investigational agents

Disqualifiers: Pregnancy, Heart disease, Epilepsy, others

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

Compensation: Varies

Number of Visits: 30

Duration: 4 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if Scrambler Therapy can reduce pain in patients with corticobasal syndrome. The therapy uses electrical signals to trick the brain into feeling non-painful sensations instead of pain. The goal is to see if this treatment can lower pain levels significantly over a short period. Scrambler Therapy is a noninvasive technique that substitutes pain information with non-painful sensations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used an investigational agent for pain control in the past 30 days.

What data supports the effectiveness of the treatment Scrambler Therapy for neuropathic pain?

Research shows that Scrambler Therapy, a noninvasive treatment, can significantly reduce chronic neuropathic pain by replacing pain signals with 'non-pain' signals. Studies have demonstrated its effectiveness in decreasing pain scores and improving quality of life, especially in cases resistant to other treatments. ^{1 2 3 4 5}

Is Scrambler Therapy safe for humans?

Scrambler Therapy is generally considered safe for humans, as it is a non-invasive treatment that has received clearance from the United States Food and Drug Administration for treating various types of pain, including acute, postoperative, and chronic pain. ^{1 2 3 5 6}

How is Scrambler Therapy different from other treatments for neuropathic pain?

Scrambler Therapy is unique because it uses a noninvasive method to send 'non-pain' signals through the skin to change how the body perceives pain, unlike traditional methods that block pain signals. It is particularly effective for pain that doesn't respond to standard treatments like opioids. ^{1 2 4 5 7}

Research Team

Alexander Pantelyat, MD

Principal Investigator

Department of Neurology, Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for English-speaking men and women over 50 with corticobasal syndrome (CBS) who experience daily pain above a moderate level. They must understand the study, agree to participate, and have a life expectancy of more than 90 days. It's not for pregnant or nursing women, those with certain metal implants, heart conditions, epilepsy, skin issues affecting electrode placement, or anyone using investigational pain agents recently.

Inclusion Criteria

Your doctor believes you will live longer than 90 days.

I am 50 or older with chronic back pain, averaging more than 4 out of 10.

I understand the study's demands and risks and am willing to consent.

Exclusion Criteria

You have a medical condition that could affect the study goals.

I haven't used experimental pain medication in the last 30 days.

I do not have open sores that would interfere with using electrodes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TENS or Scrambler Therapy for pain relief, with eventual crossover to Scrambler Therapy for all participants

4 weeks

Weekly visits for treatment sessions

Follow-up

Participants are monitored for changes in pain scores and global impression of change

8 weeks

Follow-up assessments at Day 30 and Day 90

Treatment Details

Interventions

• Scrambler Therapy
• TENS treatment

Trial Overview The trial is testing scrambler therapy (ST), comparing it to transcutaneous electrical nerve stimulation (TENS) for treating neuropathic pain in CBS patients. Participants will be randomly assigned to receive either ST or TENS first; all will eventually get ST. The treatment involves placing ECG electrodes on painful areas for up to 40 minutes.

Participant Groups

Group I: Scrambler therapy Experimental Treatment 1 Intervention

Scrambler Therapy is a non-invasive neuromodulation approach using superficial electrocardiogram (ECG) electrodes in paired channels on the involved dermatomes to send "non-pain" information along the existing nerve pathways, which can modify peripheral and central sensitization.

Group II: TENS treatment Active Control 1 Intervention

Transcutaneous electrical nerve stimulation (TENS) is a battery-powered device which delivers low-voltage electrical current through superficial electrocardiogram (ECG) electrodes placed on the surface of the skin to provide pain relief.

Scrambler Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Calmare MC5-A Scrambler Therapy for:

• Chronic neuropathic pain
• Oncologic pain
• Chemotherapy-induced peripheral neuropathy

Approved in European Union as Calmare MC5-A Scrambler Therapy for:

• Chronic neuropathic pain
• Oncologic pain

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Scrambler therapy significantly reduced pain levels in patients with chronic neuropathic pain, showing a 15% decrease in pain scores over 2 weeks, indicating its efficacy as a noninvasive treatment option.

The effectiveness of scrambler therapy varied based on the type of neuropathic pain, with better outcomes observed in patients experiencing paroxysmal pain compared to those with persistent pain, suggesting that understanding pain phenotypes could enhance treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential response to scrambler therapy by neuropathic pain phenotypes. Min, YG., Baek, HS., Lee, KM., et al.[2021]

Scrambler therapy (ST) is a safe and well-tolerated noninvasive treatment for chronic pain, particularly effective for neuropathic pain conditions like chemotherapy-induced peripheral neuropathy, based on a systematic review of 21 studies.

The therapy not only provides significant pain relief but may also lead to secondary benefits such as reduced medication use and improved sensory and motor symptoms, although more extensive studies are needed to confirm its efficacy in nociceptive pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Scrambler Therapy in Treating Chronic Pain Syndromes: A Systematic Review. Karri, J., Marathe, A., Smith, TJ., et al.[2023]

Scrambler Therapy significantly reduced chronic pain in 201 patients, with average pain scores dropping from 7.41 to 1.60 after ten treatment sessions, indicating its efficacy in managing refractory neuropathic pain.

The therapy was found to be safe, with only 7 patients discontinuing due to lack of results and very few adverse events reported, suggesting it is a viable non-invasive option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis. Compagnone, C., Tagliaferri, F.[2016]

Scrambler therapy (ST) is a promising noninvasive treatment for chronic neuropathic and cancer pain, utilizing artificial neurons to transmit 'non-pain' signals through C fiber receptors.

In three case studies of patients suffering from chemotherapy-induced peripheral neuropathy, scrambler therapy demonstrated successful pain relief, highlighting its potential as an alternative when traditional pain management methods are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler therapy: A ray of hope for refractory chemotherapy-induced peripheral neuropathy. Ahuja, D., Bharati, SJ., Gupta, N., et al.[2020]

Scrambler Therapy (ST) is a noninvasive treatment for chronic neuropathic and cancer pain that uses a novel mechanism involving the transmission of synthetic 'non-pain' information through C fiber receptors, differing from traditional pain relief methods like TENS.

The therapy aims to provide immediate pain relief and long-lasting analgesia after a series of 10 to 12 treatments over two weeks, specifically targeting patients who do not respond well to opioids and other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inside the Scrambler Therapy, a Noninvasive Treatment of Chronic Neuropathic and Cancer Pain: From the Gate Control Theory to the Active Principle of Information. Marineo, G.[2023]

Calmare Scrambler Therapy (ST) did not show statistically significant differences in reducing chronic neuropathic pain or improving quality of life compared to sham treatment in a study of 47 military service members.

Despite the lack of measurable efficacy, both active and sham treatments resulted in clinically meaningful pain reductions, and 90% of participants perceived the treatment as a success, highlighting the importance of patient perceptions in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life. Nayback-Beebe, A., Panula, T., Arzola, S., et al.[2020]

In a case series of 25 patients with cancer pain from skeletal and visceral metastases, scrambler therapy resulted in a significant pain reduction, with all patients experiencing at least 50% relief and an average pain score dropping from 8.4 to 2.9 after treatment.

Scrambler therapy was well-tolerated with no adverse events reported, and it allowed for a reduction in opioid dosage, suggesting it could be a safe and effective alternative for managing cancer pain after standard treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of scrambler therapy for pain induced by bone and visceral metastases and refractory to standard therapies. Notaro, P., Dell'Agnola, CA., Dell'Agnola, AJ., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Differential response to scrambler therapy by neuropathic pain phenotypes. [2021]

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

The Use of Scrambler Therapy in Treating Chronic Pain Syndromes: A Systematic Review. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis. [2016]

4. India pubmed.ncbi.nlm.nih.gov

Scrambler therapy: A ray of hope for refractory chemotherapy-induced peripheral neuropathy. [2020]

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

Inside the Scrambler Therapy, a Noninvasive Treatment of Chronic Neuropathic and Cancer Pain: From the Gate Control Theory to the Active Principle of Information. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Pilot evaluation of scrambler therapy for pain induced by bone and visceral metastases and refractory to standard therapies. [2018]