WAT Medical, a maker of precise, wearable and smart medical products, announced the results of a clinical study conducted for an anti-migraine device by the HeadaTerm, for the treatment of migraines. The HeadaTerm TENS device was shown to decrease pain at an 11.8% better rate than many acute migraine medications.
The blind, randomized controlled trial was conducted by Dr. Nihat M. Hokenek and his team at the Emergency Department of Kartal Dr. Lütfi Kirdar Training and Research Hospital in Istanbul, Turkey.
The patients were divided into 2 groups: a control group, and a verum group. Patients in the verum group include those who used the device for the first time. Both groups were provided with visually indistinguishable devices. Each underwent therapy for a total of 20 minutes. Using the Visual Analog Scale (VAS), the patients’ perceived changes in pain intensity were recorded at the 20- and 120-minute marks after therapy initiation. After 120 minutes, patients’ individual needs for additional treatment were assessed. Additionally, their self-reported comfort levels were assessed using a Likert-type verbal scale, says a press release.
Among the 151 patients who were assessed after being admitted to the emergency ward, the control and verum groups were each assigned with 39 patients from this pool. The VAS change for the verum group from 0 to 120 minutes was -65.46 ± 25.11, and for the control group, it was -9.46 ± 2.61 (p <0.001). Verbal scores in the 120-minute mark were found to be 1.2 for control group and 4.5 for the verum group (p <0.001). 30 patients (76.92%) in the control group and 1 (2%) in the verum group had additional analgesic requirement after 120 minutes.
The study concluded that TENS therapy conducted by HeadaTerm is a fast-acting treatment of acute migraines.
HeadaTerm is a wearable anti-migraine device that uses precisely designed electrical stimulation to target the central nervous system’s pain receptors by releasing pain-countering neurotransmitters. The device has been cleared by the FDA as well as other international medical agencies including Health Canada, CE, TGA and Israel.