The Effect of Non-Invasive Vagal Nerve Stimulation Combined With Self-Managed Therapy in Individuals With Myogenic Temporomandibular Dysfunction

NARecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 8, 2025

Primary Completion Date

January 22, 2026

Study Completion Date

February 3, 2026

Conditions
Temporomandibular Disorders (TMD)
Interventions
OTHER

Self-Management Therapy

Participants in this group will receive self management therapy. The self-administered therapy programme will consist of prevention of parafunctional activities, information about sleep hygiene and home exercise programmes, the effectiveness of which has been reported in the literature and is in line with the International Delphi Guidelines. Home exercises will start with 2 times a day, 8 repetitions and progress will be made weekly according to the patient's condition.

DEVICE

Placebo Non-Invasive Vagal Nerve Stimulation

Participants in this group will receive self managemenet therapy and placebo vagal nerve stimulation. For Placebo Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, the technique will be similar to active stimulation. The VaguStim device will be set to 0 Hz by the practitioner, indicating that no actual stimulation is being delivered. Patients will be told that they will not be able to feel the current due to its lower intensity during the intervention, without explaining the true nature of the placebo stimulation.

DEVICE

Non-Invasive Vagal Nerve Stimulation

Participants will receive Non-Invasive Vagal Nerve Stimulation and self management therapy. : Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, CE certified (CE No: 2460) non-invasive stimulation device will be applied with. The application will be performed with 3 different sized electrodes (small, medium, large) specially designed according to the size of the inner ear. The stimulation will be delivered bilaterally from the symba concha and tragus regions innervated by the auricular branch of the n.vagus, which guarantees effective and targeted vagal modulation. With reference to the studies in the literature; VaguStim application frequency will be 25 Hz, pulse width 250 µs, current level 0.5 mA with biphasic waveform. The treatment will continue 3 days a week for a total of 6 weeks, with each session lasting 20 minutes.

Trial Locations (1)

33140

RECRUITING

Toros University 45 Evler Campus, Mersin

All Listed Sponsors
lead

Toros University

OTHER