Novel Magnetic Pulse Therapy Device Reduces Diabetic Neuropathic Foot Pain by Over 77%
According to researchers at the University of Maryland Center for Diabetes and Endocrinology located on the University of Maryland Medical Center Midtown Campus, transcutaneous magnetic stimulation (TCMS) has been found to reduce pain for most patients receiving the adjunctive therapy for foot pain related to diabetic neuropathy.
In a pilot study led by Kashif M. Munir, MD, associate professor of medicine at the University of Maryland School of Medicine and medical director at the UM Center for Diabetes and Endocrinology, a single TCMS treatment session reduced mean self-reported pain scores by 77.7 percent immediately post-treatment.1
"Currently, there is no ideal treatment for diabetic neuropathy," says Munir. "The few medications that have been approved to palliate may often be associated with side effects." In the initial trial of TCMS, after a one-time treatment, all subjects had lower pain scores. "Some people experienced pain relief for weeks, and others only for a day or two. Our next step is to see if recurrent treatment with TCMS can produce an ongoing benefit for more patients," Munir explains.
How TCMS Works
The idea for applying TCMS therapeutically for diabetic neuropathy came from the technology's efficacy in treating other conditions involving neuropathic pain such as migraine, spinal stenosis and post-traumatic peripheral neuropathy.
The TransCutaneous Magnetic Stimulator device (ZyGood LLC, Dayton, Maryland) was developed in collaboration with the University of Maryland James Clark School of Engineering. The magnetic pulse therapy, which involves placing each foot atop a shoebox-sized device designed to treat a single foot at a time, is a noninvasive, fast (~5 minutes for each foot), relatively inexpensive intervention associated with mild, if any, side effects. The TCMS integrated magnetic pulser (IMP) device uses a magnetic coil to produce a 1.0 - 1.2T force similar in strength to the magnet of a basic modern MRI system. A series of magnetic pulses fired in rapid succession creates a small electrical current that disrupts the nerve pain. According to the patent issued for the TCMS device,
The IMP system consists of a single magnetic coil that is situated within the same enclosure that includes an electrical pulse generator. The electrical pulse generator creates the intense electrical pulses that the magnetic coil converts into intense magnetic pulses. Within the human body, these magnetic pulses convert back to electrical pulses that cause the pain neurons to be unable to send the correct message to the brain which is the message that the brain recognizes as being pain.2
Because this therapeutic mechanism is not specific to diabetic neuropathy but works for any foot pain, the TCMS device also could be used to treat chemotherapy-induced peripheral neuropathy and even plantalgia. The device is built on the same technology platform as an FDA-approved transcranial magnetic stimulator (TMS) device for the treatment of migraine headaches, which has been in use for decades and with which no adverse effects have been reported.3
TCMS for Diabetic Neuropathy Pilot Trial Study Design & Results
In the initial trial of the device, eight patients with diabetic peripheral neuropathy and self-rated pain in both feet of 5 or greater on a numerical pain-rating scale (NPRS) received a single treatment session with the TCMS device. The device delivered 1.2T magnetic pulses every 6 seconds for 5 minutes, first on the plantar surface and then on the dorsal surface, on each foot. Five minutes after this bilateral treatment and a Standard Pain Measurement Walk (SPMW) of 10 steps in stocking feet on a hard surface, self-reported pain scores were measured again. Prior to treatment, the mean baseline NPRS was 5.8 (+/- 1.0); five minutes after treatment, the mean NPRS was just 1.3 (+/- 1.9), representing a 77.7 (+/- 36.5) percent decline in pain.
To assess the durability of these therapeutic results, patients had follow-up visits at 7 and 28 days. Mean NPRS at 7 days was 2.9 (+/- 2.8), still a 53.2 (+/- 42.4) percent improvement over baseline. At 28 days, mean NPRS was 4.1 (+/-3.3), suggesting that some patients no longer reaped any palliative benefit from TCMS while others were still experiencing lingering, albeit waning, good results.
Current Trial: A Double-Blinded Look into Efficacy of Ongoing TCMS Therapy
A second trial, which is exploring whether TCMS can be used as an ongoing effective palliative treatment, is currently enrolling 20 patients who have a baseline NPRS of 5 or greater. These patients will be randomized into two groups during treatment: One group of 10 patients will receive magnetic pulse treatment with the TCMS device, and the other group will go through the same application of the device switched to sham mode. Only the person turning on the device will be aware of whether the device is in actual treatment or sham treatment mode, and the mode will be determined by a number inside a sealed envelope randomly selected for the patient and opened immediately before treatment.
All patients will go through treatment motions by placing their feet atop the device. Actual treatment will consist of 100 magnetic pulses delivered to each foot at the rate of one every six seconds. With pulsed treatment, patients may experience involuntary muscular jerking expected to be unharmful and painless. After waiting five minutes after treatment is completed, patients will take a SPMW and report their pain on the NPRS. Because pain levels can vary throughout the day, and many people with diabetic neuropathy experience greater pain at night, patients will also be given a diary with instructions for taking their NPRS pain scores during the 28-day trial period twice per day: within two hours of waking and right before bedtime. They will also be asked to track and describe any unwanted side effects from the treatment.
Patients who continue to have at least a pain level of 1 on the NPRS will report back to the clinic for TCMS treatment on day 7, 14, 21 and 28 (all +/- 4 days). Patients with no diabetic neuropathy foot pain on a given week will skip that week's treatment.
The primary outcome measure of the study will be patients' pain levels. Secondary outcomes include patient satisfaction with the treatment as well as any changes to their pain medication regimens before treatment and at day 28. These measures will determine if TCMS is safe and effective and whether or not further investigation into this treatment strategy is warranted.
TCMS: A Safe Therapy That May Improve Neuropathy
While TCMS differs from other transcutaneous magnetic-driven therapies such as pulsed electromagnetic field (PEMF) therapy insofar that it limits its promise to alleviating pain rather than restoring circulation and promoting the healing of tissues, there is anecdotal evidence that it might increase sensation in the feet indirectly.
"We've had one or two people say their sensation has improved after this therapy," Munir says. He mentions that a few patients have noted that they "feel something different in their feet" and a tingling feeling during treatment. Also, theoretically, there is a potential for the electrical disruption of the pain signal to make foot pain worse; however, to date the UM Center for Diabetes and Endocrinology hasn't seen any side effects from TCMS in the patients they have treated with this investigational therapy.
For more information about the current TCMS clinical trial, contact Devon Nwaba at 410-706-7764.
- NCT04000867: Treatment for Foot Pain Caused by Diabetic Neuropathy Using Recurrent TransCutaneous Magnetic Stimulation (TCMS)
- University of Maryland Center for Diabetes and Endocrinology
- Pancreas Transplantation at the University of Maryland Medical Center
- Schedule Grand Rounds at your hospital with a UMMC specialist
1Satyarengga M, Munir KM. Transcutaneous magnetic stimulation: a novel treatment of diabetic peripheral neuropathy. J Endocrinol Soc. 4(S1):Apr-May 2020;MON-LB109. doi: 10.1210/jendso/bvaa046.2166
2Fischell RE, Kaye ST, inventors; ZyGood, Inc., assignee. Integrated magnetic pulsation device for the treatment of foot pain. US patent 10,589,117. March 17, 2020.
3Fischell RE, Fischell DR, Upton ARM, inventors; Neuralieve Inc., assignee. Means and method for the treatment of migraine headaches. US patent 6,402,678B1. June 11, 2002.