Clinical Trials

Inclusion Criteria:

• Pain or symptoms of CIPN of >= 3 months duration, for which the patient wants intervention
  • Note: neurotoxic chemotherapy must have been completed >= 3 months prior to registration and there must be no further planned neurotoxic chemotherapy for > 5 months after registration
• Patients have to relate that tingling or pain was at least a four out of ten problem =< 7 days prior to registration, on a 0-10 scale where zero was no problem and ten was the worst possible problem
  • Note: the patient is expected to have tingling or pain of at least 4/10 at the time of the first treatment
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
• Life expectancy >= 6 months
• Ability to complete questionnaire(s) by themselves or with assistance
• Ability to provide informed written consent
• Case review by the study chair, or designate, as a case where treatment should be tried

Exclusion Criteria:

• Any of the following:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception
• Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
• Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring devices
  • Note: metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices
• History of myocardial infarction or ischemic heart disease within the past six months
• History of epilepsy, brain damage, use of anticonvulsants for seizure prevention, concurrently using ketamine, symptomatic brain metastases
• Skin conditions such as open sores that would prevent proper application of the electrodes
• Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
• Currently receiving gabapentin or pregabalin and not willing to be weaned off of these medications prior to Scrambler therapy initiation
  • Note: it is OK to continue these medications in patients who are receiving TENS
• History of peripheral neuropathy prior to receiving neurotoxic chemotherapy
• Prior treatment with Scrambler therapy