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Patients will receive TaVNS stimulation for 30 minutes, twice a day (between 9:00 to 10:00 and 15:00 to 16:00), for 7 consecutive days. Stimulation pulses (30 Hz frequency, 300 μs pulse width) were generated by a commercial transcutaneous auricular vagus nerve stimulation unit (tVNS 501，Jiangsu, China), and the amplitude was increased to the maximum amount tolerated by the subject without pain, then stimulate for 30 min. All subjects were told that they may or may not feel any sensation from the stimulation, and the unit is packed in an opaque bag throughout the treatment.

Patients will receive sham TaVNS stimulation for 30 minutes, twice a day (between 9:00 to 10:00 and 15:00 to 16:00), for 7 consecutive days. Stimulation unit was active for the first 30s, stimulation pulses (30 Hz frequency, 300 μs pulse width) were generated by a commercial transcutaneous auricular vagus nerve stimulation unit (tVNS 501，Jiangsu, China).Then dropped to zero stimulation during 15s and shut down. All subjects were told that they may or may not feel any sensation from the stimulation, and the unit is packed in an opaque bag throughout the treatment.

Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) works by stimulating the auricular branches of the vagus nerve (mainly distributed in the concha cavity and conchae) through electrical impulses.Electrodes were placed on the concha of the left ear after cleaning the skin of the concha with a small disposable alcohol pad. Stimulation pulses (frequency 30 Hz, pulse width 300 us) were generated by TaVNS device, the amplitude was increased within 30 seconds to the subject produced a tingling sensation, and then descend within 15 seconds to the maximum tolerable amount without pain. Inform the subject that "target stimulus has been reached", then stimulate for 30 minutes.

Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)

Place electrodes on the concha of the left ear after cleaning the skin of the concha with a small disposable alcohol pad. The same stimulation pulses (30 Hz frequency, 300 us pulse width) were generated by the same device, the amplitude was increased within 30 seconds to the subject produced a tingling sensation, and then ramps down to zero stimulus over 15 seconds. The subjects were told that "the target stimulus has been reached". Patients receive sham stimulation for 30minutes.

Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)

Yamei Tang, M.D.;PHD.

Yamei Tang, M.D., PhD.

Qiuyan Chen

Dongping Chen

Dong Zheng

This multi-center, randomized, double-blind, sham-controlled trial aims to investigate the effect and safety of TaVNS in treating radiotherapy-related neuropathic pain.

Radiotherapy-related neuropathic pain(RRNP) is one of the most distressing complications after radiotherapy for head and neck cancers. The prevalence of neuropathic pain in cancer pain patients is as high as 31-45%.Our previous RCT of pregabalin for RRNP showed that nearly 41.6% of patients still did not achieve 30% pain relief even with standard doses of pregabalin. At the same time, drug side effects such as dizziness and obesity are common, and a dose titration process for at least one week is required.Therefore, new treatments that effectively relieve pain and improve quality of life must be explored.

Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) works by stimulating the auricular branches of the vagus nerve through electrical impulses. Previous studies have shown it can relieve various pains including migraine, cluster headache, musculoskeletal pain with few adverse events. This study plans to evaluate the efficacy of TaVNS versus sham stimulation for relieving RRNP, and assessed its safety.

An independent physiotherapist performs vagus nerve stimulation or sham stimulation according to the group envelope; Investigators (physicians) are only responsible for administering medications other than vagus nerve stimulation;Before treatment, all subjects were told that the intensity of this treatment method may not be felt; The therapeutic device is placed in an opaque airtight pouch that is invisible to both the clinician and the patient during use. The control strategy used "transient sham stimulation", which allows for subjects blinding while delivering a true placebo treatment. Data analysts will be blinded to the allocated treatment group.

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancers: A Multi-center, Randomized, Double-Blind, Sham-Controlled Trial

The primary outcome of this trial is to evaluate the change from baseline to Day 7 with respect to pain intensity based on the NRS, which evaluates the average pain in the last 24 hours from "0" indicating "No Pain" to "10" indicating "Pain as bad as you can imagine".

The Chinese version of Brief Pain Inventory (Short-Form) is used to assesses pain severity and inference, which has been widely used in neuropathic pain. The Pain severity score is assessed as mean of the four pain items (i.e., pain at its worst, least, average, and now)29. Functional inference is measured by the BPI Interference in 7 items, which includes General activity, Mood, Walking ability, Work, Social relations, Sleep and Life enjoyment. Each item is scored on a 10-point scale. Lower scores indicate alleviative functional interference.

The Chinese version of short form of the Profile of Mood States (POMS-SF) has been recommended as core outcome measures of emotional functioning in chronic pain clinical trials. It's a 30-item scale to evaluate patients' mood states, including 5 negative mood states (Tension-anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, Confusion-Bewilderment) and 1 positive mood state (Vigor-Activity).Lower scores indicate alleviative mood disturbance in all fields except the positive one.

The Chinese version of WHOQOL-BREF is a brief version of The World Health Organization Quality of Life (WHOQOL), which has been widely used in clinical studies on cancer and neuropathic pain. In the questionnaire, a total of 26 items assess 4 domains of quality of life, including physiology, psychology, social relationship and environment. Lower scores correspond to poorer quality of life.

The Chinese version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is widely used to assess various chronic disease-related fatigue states. The FACIT-F is a self-report scale. It comprises 13 items with five-point response options from 0 to 4. Except for items An5 and An7, which are forward scoring, all other items are reverse scoring. The total score ranges from 0 to 52, with a higher total score representing less fatigue.

The Patient Global Impression of Change (PGIC) is self-evaluation of the patient's overall change on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse), and is obtained at the end of the study. Treatment success is defined as "much" or "very much" improved. The PGIC question will ask: "With respect to your overall radiotherapy-related neuropathic pain symptoms, how will you describe yourself now compared to immediately before starting study medication?"

The Clinical Global Impression of Change (CGIC) is single item questionnaire that asks the investigator to evaluate the subject's overall symptom change on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse), and is obtained at the end of the study. Treatment success is defined as "much" or "very much" improved. The CGIC question will ask: "With respect to the subject's overall radiotherapy-related neuropathic pain symptoms, how will you describe him (or her) now compared to immediately before starting study medication?"

The serum inflammatory factors including: serum tumor necrosis factor-α (TNF-α) level; serum interleukin-1beta (IL-1β) level; serum interleukin-6 (IL-6) level; serum interleukin-10 (IL-10) level.Whole blood was centrifuged, serum was then stored at -80°C. The inflammatory factors were detected by ELISA in the laboratory

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain	NCT05543239	Neuropathic Pai... Radiotherapy Si...	Transcutaneous ... Sham Transcutan...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain	NCT05543239	Neuropathic Pai... Radiotherapy Si...	Transcutaneous ... Sham Transcutan...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for transcutaneous auricular vagus nerve stimulation