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Clinical Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined with 3M Physiotherapy for the Treatment of Temporomandibular Joint Disorders

The improvement of temporomandibular joints disorders with somnipathy using transcutenous auricular vagus nerve stimulation combined with 3M physical therapy:A single-center,single-blind,randomized controlled clinical trail

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096961
Enrollment
Unknown
Registered
2025-02-10
Start date
2024-12-12
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders(TMDs)

Interventions

Targeted-Closed-Loop Stimulation Experimental Group (Exposure Group):Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Therapy
Control Group (Non-exposed Group):Transcutaneous Auricular Vagus Nerve Stimulation Sham Treatment

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.In accordance with the diagnostic criteria for TMDs research; 2.Pittsburgh Sleep Quality Index (PSQI) score > 7; 3.No history of neurological or psychiatric related diseases; 4.No significant cognitive impairments, capable of cooperating to complete the corresponding rehabilitation training; 5.Male or female, aged between 18 to 80 years; 6.Patients who have not received various neuromodulation rehabilitation treatments; 7.No contraindications for taVNS and neuromuscular electrical stimulation; 8.Volunteers who are willing to participate in the study and have signed an informed consent form;

Exclusion criteria

Exclusion criteria: 1. Suffering from other mental health diseases (dementia, Parkinson's disease, depression, anxiety, schizophrenia, bipolar disorder, etc.); 2. Have uncontrolled epilepsy, that is, have had seizures within 4 weeks before enrollment; 3. Cardiac arrhythmia or other abnormalities; 4. History of respiratory illness or disorder, including dyspnea and asthma; 5. History of vasovagal syncope; 6. Receiving other neurostimulation/modulation therapy; 7. Difficulty in communication and understanding, unable to cooperate with the completion of the test; 8. Women who are pregnant or breastfeeding;

Design outcomes

Primary

MeasureTime frame
Fonseca Anamnestic Index;variability in mouth opening degree;Changes in electrocardiographic characteristics (heart rate, heart rate variability)and respiratory characteristics;Visual Analogue Scale (VAS) pain scores;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI) assessment scores;

Countries

China

Contacts

Public ContactZhen Liu

The Third Affiliated Hospital of Guangzhou Medical University

lzym3798@163.com+86 20 81292183

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026