Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device

FluxWear, INC

Status: Invitation-only

Conditions: Chemotherapy Induced Peripheral Neuropathy; Chemotherapy Induced Pain Neuropathy; Chemotherapy Induced Peripheral Neuropathy (CIPN); Chemotherapy Induced Neuropathic Pain

Treatments: Device: SHIFT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07061769

1391997

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 in the brain
• History of brain bleed in the last six months
• History of suicidal behavior, bipolar disorder, schizophrenia
• Active radiation over the scalp
• Brain metastases
• Currently participates in other neuropathic pain studies
• Has any other medical condition that would prevent them from participating, including scalp wounds, hyperhidrosis, sensitive scalp, rash
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Treatment Device

Experimental group

Treatment:

Device: SHIFT

Sham Device

Sham Comparator group

Treatment:

Device: SHIFT