TransFORM-TMD: a feasibility device trial (v 1.0)
Research type
Research Study
Full title
TransFORM-TMD: Transcutaneous auricular vagus nerve stimulation FOR Myalgia Temporomandibular Disorder and depression: a parallel-arm, double-blind, randomised, sham-controlled, feasibility device trial
IRAS ID
361775
Contact name
Tiago Costa
Contact email
Sponsor organisation
NuTH
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Temporomandibular disorders (TMD) are a group of musculoskeletal conditions affecting the jaw joint and muscles. TMD is common, with up to 1 in 15 people experiencing problems such as pain in the face, headache, and difficulty moving the jaw. For some patients with painful myalgia TMD (mTMD), where pain is related to jaw muscles, symptoms can be persistent, with little help from simple treatments, leading to significant impacts on their life. Depression is also common in people with TMD and can be related to the impact of their symptoms on everyday life. Current specialist treatments for persistent mTMD include off-label medications which can have unpleasant side effects.
Transcutaneous auricular vagus nerve stimulation (taVNS) involves painless electrical stimulation of the vagus nerve with a small electrode placed on the ear. The vagus nerve is part of the autonomic nervous system, which controls unconscious body functions. taVNS is useful in other painful conditions like migraine, and evidence suggests a benefit in depression. There is currently very little evidence on whether taVNS can help people with TMD. However, other approaches used in migraine (medications, Botulinum toxin injections) have proved beneficial in TMD.
TransFORM-TMD is a feasibility trial. We will give 40 people with TMD a taVNS device to use at home for 12 weeks. Half of the devices will function normally, and half will provide no stimulation (sham device). Participants will not be able to tell which device they have been given. The main outcome will be to see whether running a definitive trial of taVNS in the future is possible. We will also compare whether TMD and depression symptoms improve in people who get the taVNS device, compared to those who receive a sham device.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0236
Date of REC Opinion
18 Dec 2025
REC opinion
Further Information Favourable Opinion