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Clinical Trials in the USA / NCT07061769
Enrolling by invitation Not applicable

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

NCT07061769 · tracked via the Priya Life Science USA tracker
Sponsor
FluxWear, INC
Phase
Not applicable
Started
2025-06-23
Last updated
2025-07-11

Condition(s) studied

Chemotherapy Induced Peripheral NeuropathyChemotherapy Induced Peripheral Neuropathy (CIPN)Chemotherapy Induced Pain NeuropathyChemotherapy Induced Neuropathic Pain

Investigational drug(s) / intervention(s)

SHIFT

SHIFT: SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Decrease in Neuropathic Pain Intensity — 12 weeks
    Measured through scores in the Neuropathy Pain Scale. The Neuropathy Pain Scale uses a range a 0 to 10, with 0 being no pain/sensation and 10 being the most intense pain/sensation imaginable.
  • Decrease in Numeric Pain Rating. — 12 weeks
    Measured through Numeric Pain Rating surveys. The numeric pain rating scale uses a range of 0 to 10, with 0 being no pain and 10 being the worst pain possible.
  • Improvement in Neuropathic Pain Symptoms — 12 weeks
    Measured in weekly scores in the Neuropathic Pain Symptom Inventory. The inventory uses a scale of 1 to 10, with 1 being the no symptom and 10 being the worst symptom imaginable.

Trial sites (1)

FacilityCityRegionStatus
Hoag Spine Institute Newport Beach California

Other trials for the same condition

Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain Active, not recruiting
The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07061769 on ClinicalTrials.gov ↗ ← All trials in the USA