Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
This study is a randomized, double-blind, sham-controlled feasibility trial designed to assess the acceptability and preliminary efficacy of Transcutaneous Auricular Neurostimulation (tAN) for individuals with Temporomandibular Disorders (TMD). Approximately 40 participants will be enrolled to evaluate whether daily, home-based tAN sessions-which deliver mild electrical pulses to the auricular branch of the vagus nerve-can effectively reduce chronic orofacial pain and improve associated cognitive and psychosocial dysfunctions. The study monitors feasibility through retention and adherence rates while tracking secondary outcomes such as pain intensity, cognitive flexibility, and mood changes using validated scales and wearable smartwatch data . Ultimately, this research aims to generate the critical data necessary to inform larger clinical trials and potentially offer a non-pharmacological, non-invasive treatment option for patients refractory to traditional TMD therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years.
- •Diagnosis of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).
- •Pain intensity of at least 4/10 on the Numeric Rating Scale (NRS) over the past two weeks.
- •Chronic pain duration of at least three months, consistent with diagnosis of chronic TMD.
- •Willingness to self-administer transcutaneous auricular nerve stimulation (tAN) at home and comply with study procedures.
- •Fluency in English to ensure comprehension of study materials and assessments.
- •Access to a smartphone or computer with internet to complete electronic study surveys and check-ins with the research team.
排除标准
- •Neurological conditions that may interfere with study outcomes, including epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
- •Use of implanted neuromodulation devices, such as vagus nerve stimulators, deep brain stimulators, or cochlear implants.
- •Unstable or severe psychiatric disorders, including active psychosis or severe depression with suicidal ideation.
- •Pregnancy or intention to become pregnant during the study period.
- •Skin conditions or other contraindications that prevent safe electrode placement on the auricular region (e.g., metal in the cymba concha that is unable or not willing to remove).
- •History of trauma (e.g., skull fracture) or periauricular surgery (e.g., temporomandibular joint replacement, acoustic neuroma removal) which would affect the location and function of the target peripheral innervation.
- •Use of both surgical and non-surgical bone conduction hearing devices.
研究组 & 干预措施
Active tAN
After the baseline assessments, participants will be trained to self-administer tAN at home according to their assigned condition (active or sham). They will be instructed to use the device daily for a minimum of two hours (maximum is 24 hours) while recording any side effects. The device's internal log will track session compliance, stimulation parameters, and usage frequency.
干预措施: Transcutaneous Auricular Neurostimulation (Device)
Sham Stimulation
The sham condition will mimic active stimulation without delivering therapeutically active parameters, defined as electrical stimulation being provided to the earpiece electrode. The sham stimulation will be passive stimulation meaning that no electrical stimulation will be provided to the participant.
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Retention Rate
时间窗: Week 6
The proportion of enrolled participants who complete both baseline and post-treatment assessments. A retention rate of ≥50% is considered feasible.
Intervention Adherence
时间窗: Week 4
The percentage of prescribed tAN sessions completed by each participant, as recorded in the internal device log. Feasibility is defined as ≥50% adherence to scheduled sessions.
Acceptability
时间窗: Week 4
Measured using a post-treatment Likert scale survey, where participants will rate comfort, usability, and willingness to use tAN again on a 1 to 5 scale. A mean acceptability score of ≥3/5 indicates feasibility.
次要结局
未报告次要终点