Scrambler Therapy for Peripheral Neuropathy

Overseen By Salahadin Abdi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Pain medications

Disqualifiers: Inability to walk, Bone metastases, Epilepsy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 2 weeks

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Scrambler Therapy, a non-invasive treatment, for pain caused by chemotherapy-induced peripheral neuropathy (CIPN) in young cancer patients. The researchers aim to determine if this therapy can reduce pain and improve physical function and quality of life. Participants will begin therapy either immediately or after a few weeks, depending on their assigned group. Ideal candidates are young adults and teens who have had cancer, experience moderate pain from CIPN, and can complete questionnaires in English. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve pain management for young cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients who are on pain medications for conditions other than chemotherapy-induced peripheral neuropathy.

What prior data suggests that Scrambler Therapy is safe for treating chemotherapy-induced painful peripheral neuropathy?

Research has shown that Scrambler Therapy might help with pain from nerve damage caused by chemotherapy. Studies suggest it could be a safe way to treat this kind of pain. For instance, some trials found that Scrambler Therapy reduced pain more effectively than standard medications.

Most patients have tolerated Scrambler Therapy well, with no major side effects commonly reported. However, some people experienced mild skin irritation where the electrodes were placed, but this was usually temporary. Overall, the evidence supports that Scrambler Therapy is both safe and potentially effective for managing chemotherapy-related nerve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Scrambler Therapy is unique because it offers a non-invasive approach to treating peripheral neuropathy, a condition often managed with medications like gabapentin or duloxetine. While those drugs typically target symptoms by altering nerve signals chemically, Scrambler Therapy works by re-training the brain to interpret pain signals as non-painful. This innovative method could potentially provide quicker relief without the side effects associated with standard pain medications. Researchers are excited about its potential to improve quality of life for patients with fewer risks.

What evidence suggests that Scrambler Therapy is effective for chemotherapy-induced painful peripheral neuropathy?

Research has shown that Scrambler Therapy (ST) can reduce pain from chemotherapy-related nerve damage. In one study, patients reported a 53% decrease in pain after 10 days of treatment. The study also found a 44% reduction in tingling and a 37% reduction in numbness. In this trial, participants will either begin ST treatment immediately or after a waitlist period of about 4 weeks. These results suggest that ST might improve physical abilities and quality of life for those with nerve pain from chemotherapy. Overall, the evidence supports Scrambler Therapy as a promising option for managing painful symptoms in cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Salahadin Abdi, M.D.

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents and young adults aged 15-39 who have had cancer, are not currently in active treatment, and suffer from moderate to severe chemotherapy-induced painful peripheral neuropathy (pain level ≥4). They must be able to complete questionnaires with or without assistance. Those with mobility issues, brain or bone metastases affecting movement, prior Scrambler Therapy, certain implants, epilepsy, skin damage where electrodes would go, or other pain conditions are excluded.

Inclusion Criteria

I experience moderate to severe pain or neuropathy from chemotherapy.

I had cancer but am not currently receiving treatment.

I am between 15 and 39 years old.

Exclusion Criteria

I have skin damage where electrodes were placed, have had ST treatment, or take pain meds for reasons other than CIPN.

My cancer has spread to my bones or brain, affecting how I walk and balance.

I need help to walk or stand.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a baseline visit including physical exams, questionnaires, and sensory tests before starting treatment

1 day

1 visit (in-person)

Treatment

Participants receive Scrambler Therapy (ST) daily, Monday through Friday, for up to 2 weeks

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored weekly for 4 weeks after ST completion, with additional assessments at months 1, 2, and 3

3 months

Weekly visits for 4 weeks, then monthly visits for 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Scrambler Therapy

Trial Overview The study tests the effectiveness of Scrambler Therapy on reducing pain from chemotherapy-induced peripheral neuropathy and improving physical function and quality of life. Participants will be randomly assigned to either receive immediate therapy or placed on a waitlist (control group) in this prospective randomized controlled trial.

How Is the Trial Designed?

Group I: Waitlist ST (Scrambler Therapy) Experimental Treatment 1 Intervention

Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.

Group II: Immediate St (Scrambler Therapy) Experimental Treatment 1 Intervention

Participant will start ST (Scrambler Therapy) treatment right away.

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?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Scrambler therapy has been shown to effectively reduce pain in a patient with diabetic peripheral neuropathy who did not respond to conventional treatments, including oral analgesics and nerve blocks.

The treatment's effectiveness was linked to the specific placement of scrambler patches, suggesting a targeted approach to pain management in diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler therapy for the treatment of diabetic peripheral neuropathy pain: A case report. Lee, YS., Park, MK., Park, HS., et al.[2022]

Diabetic neuropathies are complex disorders affecting both peripheral and autonomic nervous systems, requiring treatment based on the underlying cause rather than just symptoms, with various therapeutic options available depending on the type of neuropathy.

While there is no definitive treatment for painful diabetic neuropathy, a range of medications and nonpharmacologic therapies can be used to manage symptoms, including tricyclic antidepressants and spinal cord stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic neuropathy: pathogenesis and therapy. Vinik, AI.[2019]

Electroacupuncture (EA) has shown a high effectiveness rate of over 90% in treating various types of peripheral neuropathy, with facial paralysis and trigeminal neuralgia being the most common conditions addressed in a review of 778 studies.

The treatment typically involves specific acupoints near the affected area, with a standard session lasting 30 minutes at a stimulating frequency of 50 Hz, and often includes additional techniques like acupoint injection and moxibustion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Characteristics of clinical application of electroacupuncture therapy for peripheral neuropathy based on data mining]. Zhang, ZD., Wang, RQ., Liu, JX., et al.[2021]

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 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]

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]

Calmare (Scrambler) therapy showed a 38.1% success rate in providing at least 50% pain relief for patients with various pain conditions, particularly benefiting those with neuropathic or mixed pain types.

Factors such as the treatment site and the type of pain significantly influenced outcomes, suggesting that specific patient characteristics should be considered when selecting candidates for Calmare therapy in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a multicenter analysis. Moon, JY., Kurihara, C., Beckles, JP., et al.[2015]

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]

Diabetic neuropathy significantly impacts patients' quality of life and is linked to serious complications like foot ulcers and increased mortality, highlighting the need for effective drug treatments.

Randomized clinical trials (RCTs) evaluating treatments for diabetic neuropathy have historically been of poor quality, emphasizing the importance of well-designed studies that consider factors like neuropathy stage, outcome measures, and long-term effects to ensure meaningful results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials for drugs against diabetic neuropathy: can we combine scientific needs with clinical practicalities? Ziegler, D., Luft, D.[2019]

Spinal cord stimulation (SCS) has been shown to significantly reduce pain in patients with painful diabetic neuropathy (PDN), with low-frequency SCS providing 45% to 55% pain reduction for up to two years in small trials, and high-frequency SCS achieving 76% mean pain relief after six months in a larger study.

The studies indicated that SCS is a safe treatment option for PDN, with no unexpected safety issues reported, highlighting its potential as an effective alternative to standard pharmacological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. Strand, NH., Burkey, AR.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01290224

Study Details | NCT01290224 | MC5-A Scrambler Therapy ... RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy. PURPOSE: This phase II trial is ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30714486/

A Pilot Randomized Sham-Controlled Trial of MC5 ... Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02722434

NCT02722434 | MC5-A Scrambler Therapy or TENS ... This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation (TENS) therapy work in treating patients ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20199631

A Study Comparing Scrambler Therapy versus TENS ... This randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation (TENS) therapy work in treating patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4383262/

Pilot evaluation of Scrambler therapy for the treatment ... At the end of 10 days of treatment, average pain decreased by 53 % (p<0.0001), while tingling decreased by 44 % (p<=0.0001) and numbness decreased by 37 % (p= ...

6. bcbsm.com bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2022297.pdf

MEDICAL POLICY - TRANSCUTANEOUS ELECTRICAL ... A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN). Journal of.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0885392411002648

Scrambler Therapy May Relieve Chronic Neuropathic Pain ... In this pilot randomized trial, Scrambler therapy appeared to relieve chronic neuropathic pain better than guideline-based drug management.

8. nature.com nature.com/articles/s41598-021-89667-6

Differential response to scrambler therapy by neuropathic ... We conducted a prospective, open-label, single-arm trial to assess the efficacy and safety of scrambler therapy in patients with chronic neuropathic pain of ...