Validation of a wearable device for controlling neuropathic pain in Trigeminal Neuralgia patients: A RCT

Trigeminal Neuralgia(TN) is a relatively rare and crippling facial pain disorder. TN has an incidence of 4–5 cases per 100,000 of the population. It is nearly twice as common in women, and the incidence increases with age to around 1 in 1000 patients older than 75 years.[1] Carbamazepine is the only medication approved by the FDA for treating trigeminal neuralgia. It has level A (effective) evidence per a 2008 American Academy of Neurology (AAN) practice parameter and systematic review.[2] Surgery is often considered when pharmacologic therapies fail and more aggressive treatment is pursued. The 2008 AAN Systematic Review concluded that Gasserian ganglion percutaneous techniques (rhizotomy), gamma knife radiosurgery, and microvascular decompression “may be considered” (Level C recommendation).[3] Neuromodulation has been studied in recent times to counter this kind of neuropathic pain. Currently, devices vary in invasiveness, ranging from SPG blocks to transcranial magnetic stimulation, transcutaneous electric nerve stimulation, peripheral nerve stimulation, direct stimulation, deep brain stimulation, and acoustic stimulation.[4,5] Utilising the gate control theory of pain modulation, we have developed a device using vibrotactile stimulation to inhibit the pain pathway through preferential conduction of vibration stimuli. Vibration, a safe and feasible option, can be the most effective proposition to reduce the neuropathic pain and enhance the quality of life in these patients. The device prototype has been developed with funding fromthe DST-supported NIDHI PRAYAS project, entitled “Development of a Wearable Device for Neuropathic Pain Control in Trigeminal Neuralgia Patients,” sanctioned on May 7, 2024. The proposed device operates in conjunction with the well-established gate control theory of pain modulation. By utilising vibrotactile stimulation, the device aims to inhibit pain pathways by preferentially conducting vibrotactile stimuli, effectively "closing the gate" to pain signals.