Validation of a wearable device for controlling neuropathic pain in Trigeminal Neuralgia patients: A RCT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 2
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults more than 18 years.
- •Clinically confirmed classical Trigeminal Neuralgia (TN) according to International Classification of Headache Disorders (ICHD-3) criteria.
- •At least 3 paroxysmal episodes of pain per day, reported over the last 2 weeks.
- •TN symptoms have been present for at least 6 months.
- •The average VAS pain score has been 4 out of 10 over the past week.
- •Willingness and ability to provide informed written consent and comply with the study protocol.
- •No other known causes of neuropathy.
Exclusion Criteria
- •Secondary TN due to tumors, multiple sclerosis, vascular compression other than idiopathic classical TN, or post-herpetic neuralgia.
- •History of facial surgery, trauma, or skin condition (e.g., dermatitis, open wounds) in the stimulation area.
- •Recent invasive procedure (e.g., microvascular decompression, radiofrequency ablation) in the past 6 months.
- •Implanted neurostimulator or pacemaker e.
- •Uncontrolled psychiatric conditions, such as severe depression, anxiety, or psychosis.
- •Pregnant or breastfeeding women.
- •Substance abuse or dependency in the past year.
- •Neurological or systemic condition interfering with pain perception or response (e.g., diabetic neuropathy, epilepsy).
- •Participation in another clinical trial involving an investigational device or drug within the past 3 months.
- •Other neurological and psychiatric disorders.
Investigators
Dr Samapika Routray
All india Institute of Medical Sciences