Scrambler Therapy for Peripheral Neuropathy

Overseen by Salahadin Abdi, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Pain medications

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

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing Scrambler Therapy, which uses small electrical currents to reduce pain, on adolescents and young adults with cancer who have painful nerve damage from chemotherapy. The therapy works by interfering with pain messages sent to the brain, making the pain feel less intense. Scrambler therapy is a noninvasive treatment for chronic neuropathic and cancer pain that uses synthetic 'non-pain' information transmitted by C fiber surface receptors.

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 data supports the effectiveness of the treatment Scrambler Therapy for Peripheral Neuropathy?

Research shows that Scrambler Therapy can significantly reduce chronic neuropathic pain, including pain from chemotherapy-induced peripheral neuropathy, by replacing pain signals with non-pain signals. Studies have demonstrated its effectiveness in decreasing pain scores and improving quality of life in various conditions. ^{1 2 3 4 5}

Is Scrambler Therapy safe for humans?

Scrambler Therapy is generally considered safe for humans, as studies have focused on its use for chronic pain and neuropathic conditions without reporting significant safety concerns. ^{1 2 3 4 5}

How is Scrambler Therapy different from other treatments for peripheral neuropathy?

Scrambler Therapy is unique because it uses electrical signals to 'retrain' the brain to perceive pain differently, offering an alternative for those who do not respond well to conventional treatments for neuropathy. ^{6 7 8 9 10}

Research Team

Salahadin Abdi, M.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Scrambler Therapy (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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 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 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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a multicenter analysis. [2015]

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

Scrambler therapy for the treatment of diabetic peripheral neuropathy pain: A case report. [2022]

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

Diabetic neuropathy: pathogenesis and therapy. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Characteristics of clinical application of electroacupuncture therapy for peripheral neuropathy based on data mining]. [2021]

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

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

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

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