nVNS Treatment
DevicenVNS treatment 2x/week for 8 consecutive weeks.
Other names: vagus nerve stimulation, non-invasive vagus nerve stimulation
NCT Number: NCT07288411
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.
Trial opening soon.
Get Notified18 year–50 year
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
nVNS treatment 2x/week for 8 consecutive weeks.
Other names: vagus nerve stimulation, non-invasive vagus nerve stimulation
Time frame: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
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.
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.
To be measured using the positive and negative affect scale (PANAS).
Arpana Church
Other
Pilot Study of the Effects of Transcutaneous Non-Invasive Vagus Nerve Stimulation (nVNS) on Symptoms and Brain Mechanisms in Premenopausal Women With Temporomandibular Disorders (TMD)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07584642
Agnosia, Behavior
View Trial DetailsNCT07226505
Craniomandibular Disorders, Jaw Diseases
Maywood, Illinois, United States
View Trial DetailsNCT06781320
Craniomandibular Disorders, Jaw Diseases
View Trial DetailsNCT07401745
Craniomandibular Disorders, Facial Pain
Al Mansurah, Dakahlia Governorate, Egypt
View Trial Details