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

NCT07061769 | Enrolling By Invitation FDA Device

• 1 other identifier: 1391997
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Decrease in Neuropathic Pain Intensity

  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.

  12 weeks

• Decrease in Numeric Pain Rating.

  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.

  12 weeks

• Improvement in Neuropathic Pain Symptoms

  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.

  12 weeks

Secondary Outcomes (4)

• Decrease of pain-related interference

  12 weeks

• Decrease of pain-related stress

  12 weeks

• Decrease of pain-related anxiety

  12 weeks

• Decrease of pain-related inflammatory markers

  12 weeks

Study Arms (2)

Treatment Device

EXPERIMENTAL

Device: SHIFT

Sham Device

SHAM COMPARATOR

Device: SHIFT

Interventions

SHIFT DEVICE

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

Sham Device; Treatment Device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FluxWear, INC: lead
• Hoag Memorial Hospital Presbyterian: collaborator

Study Sites (1)

Hoag Spine Institute

Newport Beach, California, 92663, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-06

Locations

US (1)