SHIFT Device for Neuropathy

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: FluxWear, INC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called SHIFT, which uses gentle magnetic fields to help cancer patients manage nerve pain from chemotherapy. The trial aims to determine if daily use of this device can reduce pain and ease daily activities. Participants will be divided into two groups: one using the actual device and the other using a placebo device. Ideal candidates are those with chemotherapy-induced nerve pain, who can use a smartphone, and who haven't recently changed their pain treatment.

As an unphased trial, this study provides patients the opportunity to explore innovative pain management solutions before they become widely available.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you've had a change in your medical therapy for neuropathy or chronic pain in the last 14 days, you may not be eligible to participate.

What prior data suggests that this device is safe for managing neuropathy symptoms?

Research has shown that the SHIFT device, which uses gentle magnetic fields, is generally safe. Studies on similar methods of magnetic nerve stimulation indicate they can effectively reduce pain without the side effects often seen in more invasive treatments.

Additionally, using electrical stimulation at low levels, like those in SHIFT, is considered safe over the long term. This suggests that using the SHIFT device daily, as planned in the trial, should not pose significant risks.

While specific safety data for SHIFT isn't available, similar devices rarely cause serious problems. The most common issues with these devices are minor, such as skin irritation. Overall, evidence suggests that the SHIFT device is well-tolerated and has a good safety record.12345

Why are researchers excited about this trial?

Unlike the standard treatments for neuropathy, which often involve medications to manage pain and symptoms, the SHIFT device offers a non-invasive approach by directly targeting nerve function. This device is designed to modulate nerve activity, potentially restoring normal nerve function rather than just masking symptoms. Researchers are excited about this treatment because it could offer a safer alternative with fewer side effects compared to traditional drug therapies, and it might provide faster relief for patients with neuropathy.

What evidence suggests that the SHIFT device is effective for managing neuropathy?

Research has shown that magnetic fields can help reduce nerve pain. In one study, 71% of patients experienced at least 50% less pain after using magnetic nerve stimulation. Another study found that most participants had significant pain relief and improved quality of life. Additionally, up to 84.6% of patients in certain groups reported feeling less pain. In this trial, participants will receive either the SHIFT device, which uses similar technology, or a sham device. These findings suggest that the SHIFT device might effectively manage nerve pain caused by chemotherapy.16789

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who are experiencing neuropathy or pain due to chemotherapy. Participants must have been diagnosed with chemotherapy-induced peripheral neuropathy.

Inclusion Criteria

Able to use smart phone and willing to receive text messages/emails
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
See 1 more

Exclusion Criteria

History of suicidal behavior, bipolar disorder, schizophrenia
Currently participates in other neuropathic pain studies
Pregnant
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the cranial PEMF device daily and complete daily, weekly, and monthly surveys

12 weeks
1 visit (in-person) at the beginning and end for blood draw

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SHIFT
Trial Overview The study tests a cranial PEMF device called SHIFT, assessing its ability to reduce neuropathic pain and improve related symptoms in cancer patients. It involves daily use of the device, surveys, and two blood draws.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment DeviceExperimental Treatment1 Intervention
Group II: Sham DevicePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

FluxWear, INC

Lead Sponsor

Hoag Memorial Hospital Presbyterian

Collaborator

Trials
37
Recruited
17,200+

Citations

Real-world long-term outcomes of peripheral nerve stimulationPatients report clinically meaningful long-term pain relief after receiving PNS through both 60-day and permanent implant systems.
Safety and Efficacy of Magnetic Peripheral Nerve ...The primary efficacy end point was a ≥50% reduction in diabetic neuropathy pain intensity at day 30, with no increase in baseline pain ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37192232/
A Retrospective Review of Real-world Outcomes Following ...Results: Overall, 71% of patients (4,348/6,160) were responders with >= 50% pain relief and/or improvement in quality of life; pain relief among responders ...
Efficacy and Safety of Magnetic Peripheral Nerve ...Of the participants who reported improvements in pain levels, 81.3% and 84.6% of participants in the CMM + mPNS and Crossover groups reported ...
Peripheral Nerve Stimulation for Neuropathic Pain ...In the final follow-up, which included 12 participants, the median pain reduction was 47.50% with a mean of 52.30%, ranging from 0.00% to 100.00 ...
Efficacy and Safety of Magnetic Peripheral Nerve Stimulation ...Given the need for rigorous clinical evaluation, this clinical trial (the SEAT study) aimed to compare the safety and efficacy of mPNS combined ...
Safety of long-term electrical peripheral nerve stimulationCurrently, chronic stimulation at frequencies below 30 Hz and percentages of effective stimulation time below 50% is considered safe.
An Analysis of the MAUDE Data base and Implications for ...Our analysis of the MAUDE data base revealed that infection, lead migration, and skin erosion were the most commonly reported AEs associated with the use of ...
Electrical Stimulation in Diabetic Peripheral NeuropathyA phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...
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