Scrambler Therapy for Peripheral Neuropathy
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Scrambler Therapy or Sham Scrambler Therapy for 10 daily sessions over two consecutive weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants in the sham group may opt to receive Scrambler Therapy after one month
What Are the Treatments Tested in This Trial?
Interventions
- Scrambler Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
VelaSano
Collaborator