FluxWear, INC
The goal of this clinical trial is to examine a low-intensity, low-risk cranial PEMF device and its effectiveness with helping cancer patients manage neuropathy symptoms from chemotherapy. Eligible patients are individuals who have been diagnosed with chemotherapy-induced peripheral neuropathy or are experiencing pain due to chemotherapy and are eighteen to sixty. The main questions the study aims to answer are: To examine whether the application of low intensity, low frequency PEMF (by the System for Heterogeneous Integrated magnetic Field Transmission (SHIFT)) results in a significant decrease in neuropathic pain intensity. To examine if SHIFT results in a decrease of pain related interference and associated symptoms of CIPN. Researchers will compare an active, treatment arm to a placebo, SHAM arm. Participants will be required to use the device once daily, fill out daily, weekly, and monthly surveys. They will have to do one blood draw at the beginning of the study and one at the end of the study.
Inclusion Criteria: * Able to use smart phone and willing to receive text messages/emails * Has CIPN disorder/neuropathic pain related to chemotherapy * Able and willing to follow instructions * Not participated in any other clinical study within the past two months that may influence the results of this study Exclusion Criteria: * History of seizures * Hydrocephalic * Had a change in medical therapy related to the treatment of neuropathy or chronic pain in the last fourteen days * Received repetitive transcranial magnetic stimulation (rTMS) in the last 60 days * Implanted device or metal i…
SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA.