Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: M.D. Anderson Cancer Center
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.
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are on pain medications for conditions other than chemotherapy-induced peripheral neuropathy, you may not be eligible to participate.
Is Scrambler Therapy a promising treatment for Peripheral Neuropathy?Yes, Scrambler Therapy is a promising treatment for Peripheral Neuropathy because it offers an alternative for patients who do not respond well to conventional treatments, especially for those with diabetic neuropathy.125810
What safety data is available for Scrambler Therapy for peripheral neuropathy?The safety of Scrambler Therapy, also known as Calmare MC5-A Scrambler Therapy or Electro-Cutaneous Treatment, has been evaluated in several studies. A multicenter retrospective analysis focused on the efficacy and safety of Scrambler Therapy after ten sessions, indicating its non-invasive nature and use of electrocutaneous stimulation. Another study assessed the safety and efficacy of Scrambler Therapy in patients with chronic neuropathic pain, showing a significant decrease in pain scores. These studies suggest that Scrambler Therapy is generally safe for treating chronic neuropathic pain, including chemotherapy-induced peripheral neuropathy.34679
What data supports the idea that Scrambler Therapy for Peripheral Neuropathy is an effective treatment?The available research shows that Scrambler Therapy can effectively reduce pain in people with peripheral neuropathy. One study found that it significantly decreased pain levels over two weeks. Another study highlighted its success in treating chemotherapy-induced peripheral neuropathy in three cases. Additionally, a trial with military service members showed that Scrambler Therapy improved their quality of life and reduced their need for pain medication compared to a fake treatment. These findings suggest that Scrambler Therapy can be a promising option for managing chronic pain.34679
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
My cancer has spread to my bones or brain, affecting how I walk and balance.
I need help to walk or stand.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: Waitlist ST (Scrambler Therapy)Experimental Treatment1 Intervention
Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
Group II: Immediate St (Scrambler Therapy)Experimental Treatment1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
National Institutes of Health (NIH)Collaborator
References
Diabetic neuropathy: pathogenesis and therapy. [2019]Diabetic neuropathies are complex, heterogeneous disorders that encompass a wide range of abnormalities affecting both peripheral and autonomic nervous systems, causing considerable morbidity and mortality. Treatment should be based upon the underlying etiology and not symptoms alone, although symptomatic therapy is needed. Neuropathies may be focal or diffuse, proximal or distal, and involve somatic and autonomic nerves. Focal syndromes are classified as (1) entrapment syndromes or (2) mononeuropathies. Entrapment syndromes are treated by means of relieving compression within confined spaces. Mononeuropathies are due to a vascular insult and resolve spontaneously. They are best treated by supportive therapy. Proximal neuropathies are usually due to an inflammatory, vasculitic, or autoimmune condition and are best treated with specific therapies for the underlying disorder based on biopsy findings. Therapies for distal polyneuropathies include metabolic treatments (e.g., aldose reductase inhibitors, aminoguanidine, gamma-linolenic acid), autoimmune therapies, and nerve growth factors. No definitive treatment is available for painful diabetic neuropathy. Several medications have been used, among them tricyclic antidepressants, antiepileptic drugs, phenothiazines, calcitonin, local anesthetics, nonsteroidal anti-inflammatory drugs, and dextromethorphan. Nonpharmacologic therapies include surgical sympathectomy, spinal cord blockade, electrical spinal cord stimulation, and prostaglandin.
Clinical trials for drugs against diabetic neuropathy: can we combine scientific needs with clinical practicalities? [2019]Diabetic neuropathy is a chronic progressive disease accounting for considerable morbidity and reduced quality of life among patients with diabetes. Accumulating evidence suggests that the clinical and neurophysiological markers used to assess neuropathy not only predict the development of neuropathic foot ulceration, one of the most common causes for hospital admission and lower limb amputations, but are also predictors of increased mortality in diabetic patients. In addition to metabolic control, drug treatment of both incipient and clinically manifest diabetic neuropathy will be necessary for the years to come. Because 1-2% of the whole population in western societies may be affected, the search for effective drug treatment is not only a very important goal for the patient suffering from diabetic neuropathy and for the practicing physician, but also an economic task for both the health care systems and pharmaceutical companies. The validity of inferences about the clinical consequences of the use of any given agent to induce a specific pharmacologic effect will depend not only on the extent to which it affects the targeted biological phenomenon, but also on the extent to which all of the actions of the agent have been defined and the extent to which all affect the entire organism, alone and in concert. The ultimate test of the usefulness of a drug or device depends on the determination of outcomes, ideally in randomized clinical trials (RCTs) of sufficient scope and duration. The efficacy and safety of a variety of drugs based on the different pathogenetic hypotheses proposed have been evaluated in RCTs since the 1970s. However, the quality of RCTs published between 1981 and 1992 that evaluated the effects of medical treatment in diabetic polneuropathy was poor. Adequate designs for RCTs in diabetic neuropathy must consider the following criteria: type and stage of neuropathy, homogeneity of the study population, outcome measures (neurophysiological markers, intermediate clinical end points, ultimate clinical outcomes, quality of life), natural history, sample size, study duration, reproducibility of neurophysiological and intermediate end points, nonspecific effects of treatment, measures of treatment effect, the extent to which the overall trail result applies to individual patients (external validity), and the reporting of the RCTs. Trials focusing preferentially on patients with mild or moderate early stages of neuropathy over long periods of 3-5 years aimed at slowing or prevention, rather than reversal, using end point measures that have clinical and prognostic significance are most likely to produce meaningful results.
Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a multicenter analysis. [2015]Calmare (Scrambler) therapy is a novel therapeutic modality that purports to provide pain relief by "scrambling" afferent pain signals and replacing them with "non-pain" information through conventional lines of neural transmission. The goal of this study is to identify which factors are associated with treatment outcome for Calmare therapy.
Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis. [2016]Scrambler Therapy is a novel neuromodulation that works by electrocutaneous stimulation in a non-invasive manner through C fibers surface receptors. It substitutes pain information with synthetic "non pain" information. The primary aim of this study was to analyze the efficacy and safety of Scrambler Therapy after ten sessions related to different usage conditions and different learning curves that occur in a multi-center study.
Scrambler therapy for the treatment of diabetic peripheral neuropathy pain: A case report. [2022]Neuropathy secondary to diabetes mellitus often does not respond well to conventional therapy. Scrambler therapy may be an alternative treatment for otherwise intractable neuropathy.
Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life. [2020]Calmare Scrambler Therapy (ST) interferes with pain signal transmission by using nerve fibers to convey a message of normality to the central nervous system. This prospective, double-blinded, randomized trial had three aims. First, we tried to determine ST's effectiveness in reducing chronic neuropathic pain symptoms and analgesic medication use in military service members, when compared to sham treatment. Next, we examined its effect on reported mental and physical health-related quality of life. Finally, we sought to describe participant perceptions of treatment effectiveness.
Scrambler therapy: A ray of hope for refractory chemotherapy-induced peripheral neuropathy. [2020]Scrambler therapy (ST) is a novel noninvasive modality for treatment of chronic neuropathic and cancer pain using 5 artificial neurons. The principle with Scrambler Therapy is that synthetic "non-pain" information is transmitted by C fiber surface receptors. Chemotherapy-induced peripheral neuropathy can markedly deteriorate patient's quality of life and can also negatively affect compliance with the anticancer treatment. Chronic neuropathic pain presents a therapeutic challenge if resistant to pharmacological management opioids and other types of treatments. We have described here successful use of scrambler therapy in three cases of chemotherapy-induced peripheral neuropathy.
[Characteristics of clinical application of electroacupuncture therapy for peripheral neuropathy based on data mining]. [2021]To investigate the application characteristics of electroacupuncture (EA) in the treatment of peripheral neuropathy, so as to provide a basis for clinical use of EA therapy.
Differential response to scrambler therapy by neuropathic pain phenotypes. [2021]Scrambler therapy is a noninvasive electroanalgesia technique designed to remodulate the pain system. Despite growing evidence of its efficacy in patients with neuropathic pain, little is known about the clinical factors associated with treatment outcome. 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 various etiologies. A post-hoc analysis was performed to investigate whether cluster analysis of the Neuropathic Pain Symptom Inventory (NPSI) profiles could identify a subgroup of patients regarding neuropathic pain phenotype and treatment outcome. Scrambler therapy resulted in a significant decrease in the pain numerical rating scale (NRS) score over 2 weeks of treatment (least squares mean of percentage change from baseline, - 15%; 95% CI - 28% to - 2.4%; p
Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. [2022]Neuropathies, the most common complication of diabetes, manifest in various forms, including entrapments, mononeuropathies or, most frequently, a distal symmetric polyneuropathy. Painful diabetic neuropathy (PDN) in the classic "stocking" distribution is a disease of increasing prevalence worldwide and a condition for which standard medical treatment only provides modest relief. Neuromodulation offers a potential alternative to pharmacotherapies given its demonstrated efficacy in other refractory chronic neuropathic pain syndromes. High-quality evidence from randomized controlled trials (RCTs) is available in these other settings for two approaches to spinal cord stimulation (SCS): (1) conventional low-frequency SCS (LF-SCS), which modulates axonal activity in the dorsal column and is paresthesia-dependent, and (2) high-frequency SCS delivered at 10 kilohertz (10 kHz SCS), which targets neurons in the superficial dorsal horn and is paresthesia-independent.