Scrambler Therapy for Peripheral Neuropathy

LS
Overseen ByLaura Shoemaker, DO, MS, FAAHPM
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Scrambler Therapy, a non-invasive treatment, for individuals with chemotherapy-induced peripheral neuropathy (CIPN), which includes symptoms like pain, numbness, and tingling in the hands and feet. Participants will join one of two groups: one receiving Scrambler Therapy and the other not, with the option to receive therapy later. The study seeks to improve daily activities and quality of life for those affected by CIPN. Individuals who have experienced CIPN-related pain for at least three months and have been off chemotherapy for at least three months may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment options for CIPN.

Will I have to stop taking my current medications?

If you are taking gabapentin or pregabalin, you will need to stop these medications before starting the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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

Research has shown that Scrambler Therapy is safe for treating nerve pain caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). In past studies, patients generally tolerated the therapy well. The FDA has approved the low electrical signals used in the treatment, indicating a good level of safety. While some studies suggest that more research is needed for complete certainty, no major safety issues have been reported so far. Overall, Scrambler Therapy appears to be a well-tolerated option for managing the discomfort caused by CIPN.12345

Why are researchers excited about this trial?

Scrambler Therapy is unique because it offers a non-invasive approach to treating peripheral neuropathy, a condition commonly managed with medications like gabapentin, pregabalin, or duloxetine. Unlike these drugs, which often address symptoms by altering neurotransmitter levels, Scrambler Therapy works by "retraining" the brain's perception of pain through electrical stimulation, potentially reducing discomfort without the side effects associated with pharmaceuticals. Researchers are excited because this technique could provide faster relief and improve quality of life for patients with fewer adverse effects.

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

Research has shown that Scrambler Therapy, which participants in this trial may receive, can help reduce pain for individuals with long-term conditions, including chemotherapy-induced pain. One study found that 80%–90% of individuals with chronic pain experienced significant improvement after this therapy. Another study found that 6 out of 10 individuals with chemotherapy-related nerve pain had their main symptoms, such as pain or tingling, reduced by half or more by the end of treatment. While results can vary, Scrambler Therapy has provided significant relief and improved the quality of life for many patients.24678

Who Is on the Research Team?

LS

Laura Shoemaker, DO, MS, FAAHPM

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for people with chemotherapy-induced peripheral neuropathy (CIPN), which causes pain and tingling in hands and feet. Participants must have had CIPN symptoms after cancer treatment, be able to attend 10 daily sessions, and provide informed consent.

Inclusion Criteria

Life expectancy greater than six months
Able to complete questionnaires by themselves or with assistance
Able to provide informed written consent
See 5 more

Exclusion Criteria

Pregnant or nursing
Operational implanted drug delivery system, implanted electronic medical device, life supporting medical device, and/or medical monitoring device
Skin conditions such as open sores that will prevent proper application of electrodes
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Scrambler Therapy or Sham Scrambler Therapy for 10 daily sessions over two consecutive weeks

2 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension (optional)

Participants in the sham group may opt to receive Scrambler Therapy after one month

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Scrambler Therapy
Trial Overview The study tests Scrambler Therapy, an FDA-approved device that uses electrical signals to alleviate CIPN symptoms. It involves a comparison between actual Scrambler Therapy and no intervention over ten days to assess its impact on pain relief and quality of life.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Scrambler TherapyExperimental Treatment1 Intervention
Group II: Sham Scrambler TherapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

VelaSano

Collaborator

Citations

Scrambler therapy: what's new after 15 years? The results ...Patients suffering from non-cancer pain obtained positive results, with almost up to 50% pain reduction maintained throughout follow-up.
Peripheral Neuropathy Evaluation Table 2025: Scrambler ...The systematic review revealed that ST is a safe intervention with the potential for meaningful benefit and a decrease of neuropathic pain conditions, with the ...
Scrambler Therapy May Offer Lasting Relief for Chronic ...Scrambler therapy, a noninvasive pain treatment, can yield significant relief for approximately 80%–90% of patients with chronic pain.
Randomized Trial of Scrambler Therapy for Chemotherapy ...A 50% or greater reduction in primary symptom (pain or tingling) score on the last day of treatment was achieved by 6 of 10 Scrambler-treated ...
Differential response to scrambler therapy by neuropathic ...Whereas previous studies have reported 30% to 90% mean pain reductions, we noticed a rather modest efficacy in this study (22% mean reduction in ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29630779/
Scrambler therapy efficacy and safety for neuropathic pain ...Scrambler therapy efficacy and safety for neuropathic pain correlated with chemotherapy-induced peripheral neuropathy in adolescents: A preliminary study.
Scrambler Therapy: Thinking Beyond the Gate Control ...Pilot evaluation of Scrambler Therapy for the treatment of chemotherapy-induced peripheral neuropathy. ... Safety of Scrambler Therapy: a ...
Scrambler Therapy May Relieve Chronic Neuropathic Pain ...The electrical charge used in Scrambler therapy is low, and the U.S. Food and Drug Administration has approved it as safe. At the highest setting, “70” on the ...
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