Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorArpana Church
About this trial
The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD). Non-invasive vagus nerve stimulation (nVNS) is the most well researched and possibly the most effective non-invasive neuromodulation treatment for chronic pain conditions that targets the brain-gut-microbiome (BGM) axis.
Participants will be asked to come in for 2 in-clinic visits, at baseline and post treatment. Participants will also be asked to come in 2x/week for 8 consecutive weeks to receive the nVNS treatment. The in-clinic visits will include physical measures, blood draw, saliva sample, and brain MRI. Participants will be asked to collect a stool sample at home and answer online questionnaires regarding, mood, pain, and health behaviors at home, prior to the in-clinic appointments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-50
Premenopausal menstruating women*
Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise.
Specific screening reveals clinical findings that include TMJ and/or masticatory and cervical muscle pain.
Disqualifiers
Medical condition, laboratory finding, or physical exam finding that precludes participation, such as systemic arthritides, juvenile idiopathic arthritis, idiopathic condylar resorption, connective tissue disorders, mandibular osteonecrosis, mandibular and condylar fractures, salivary gland disorders (incl. history of stones or swelling), neoplasms, neurologic/neuropathic, endocrine, or immune/autoimmune diseases and congenital or developmental disorders.
Pathologic processes found on imaging including neoplasm (Exception: disc displacements and osseous pathology including osteoarthritis/osteoarthrosis).
Radiation treatment to head and neck
Prior jaw or open TMJ (including contralateral joint) surgery including plication, chondroplasty, joint replacement, disectomy, and discoplasty.
Trial design
Design model
Single group
Treatments tested in this trial
nVNS Treatment
DevicenVNS treatment 2x/week for 8 consecutive weeks.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Active nVNS TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity
To be measured using a numeric rating scale 0-10.
Time frame
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.2
Pain Unpleasantness
To be measured using a visual analog scale.
Time frame
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.3
Positive and Negative Affect
To be measured using the positive and negative affect scale (PANAS).
Time frame
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arpana Church
Lead sponsor
University of California, Los Angeles
Sponsor institution
Source ClinicalTrials.gov