Neuropathic PainRELAXNCT05543239
Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Radiotherapy-Related Neuropathic Pain
A study testing Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS) in people with Neuropathic Pain and Radiotherapy Side Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.
Trial summary
This multi-center, randomized, double-blind, sham-controlled trial aims to investigate the effect and safety of TaVNS in treating radiotherapy-related neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Radiotherapy Side Effect
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 4 sitesChina
- Study dates
- 16 Sep 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years with an estimated survival of at least 5 months;
- Prior radiotherapy for histologically confirmed cancer ≥ 6 months prior to study entry;
- Pain for at least 4 weeks with an average intensity of ≥ 4 on an 11-point numeric rating scale (NRS) in the run-in period, and pain locations in accordance with radiated innervated areas, e.g. head, face, neck and arms;
- Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score ≥ 12 in the Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS) by two trained and experienced neurology specialists.
Who cannot join
- Current diagnosis of tumor recurrence or metastasis and evidence of tumor-associated pain;
- Patients with non-radiotherapy induced neuropathic pain, e.g. postherpetic neuralgia, diabetes mellitus, HIV infection, spinal cord injury and other neurological disease;
- Use of carbamazepine, gabapentin, pregabalin, TaVNS or transcranial magnetic stimulation within the last 30 days prior to study entry;
- Other ongoing treatment for neuropathic pain, including antidepressants with norepinephrine and serotonin reuptake inhibition, calcium channel α2-δ ligands and other anticonvulsant medications, and topical lidocaine;
- Concomitant medication that may cause an adverse interaction with pregabalin, including sedative (e.g., benzodiazepines);
- Significant renal impairment: plasma creatinine>1.5mg/ml, creatinine clearance < 60 mL/min;
Show all 14Show fewer
- History of anaphylactic response to pregabalin;
- Ulceration of the auricle skin; Diagnosis of mental illness, peptic ulcer,AV III degree block, heart rate< 50/min, heart rate corrected QT interval > 450ms;
- Patients with cardiac pacemakers or implanted ECG monitoring equipment;
- Evidence of severe systemic diseases;
- Subjects with any other condition which, in the investigator's judgment might interfere the outcome of the study;
- Refuse to provide written informed consent;
- Cognitive function and language skills are insufficient to complete study questionnaires;
- Pregnant or lactating women.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yamei Tang, M.D., PhD.
- Not yet recruiting
Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center
Guangzhou, 510060
Qiuyan Chen
- Not yet recruiting
Department of Nasopharyngeal Carcinoma, The Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, 510080
Dongping Chen
- Not yet recruiting
Department of Neurology, The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, 510450
Dong Zheng
About this study
Official title: 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
This multi-center, randomized, double-blind, sham-controlled trial aims to investigate the effect and safety of TaVNS in treating radiotherapy-related neuropathic pain.
Read the detailed description
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.
- Conditions
- Neuropathic Pain, Radiotherapy Side Effect
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)
- Keywords
- Radiotherapy-Related Neuropathic Pain, Transcutaneous Auricular Vagus Nerve Stimulation, Head and Neck Cancers, Randomized controlled trials
- Medical subject headings
- Neuralgia, Radiation Injuries, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)Device
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.
Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| TaVNS | Active comparator | 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. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS) |
| Sham TaVNS | Sham comparator | 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. Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to day 7 with respect to pain intensity based on the NRS.
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".
Measured: Day 7
Secondary outcomes (8)
Change from baseline to week 16 with respect to pain intensity based on the NRS.
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".
Measured: week 16
BPI-SF
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.
Measured: day 7, week 16
POMS-SF
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.
Measured: day 7, week 16
WHOQOL-BREF
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.
Measured: day 7, week 16
FACIT-F
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.
Measured: day 7, week 16
PGIC
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?"
Measured: day 7, week 16
CGIC
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?"
Measured: day 7, week 16
Serum Inflammatory Factors
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
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start16 Sep 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yamei Tang, M.D.;PHD., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543239
- Sponsor's protocol ID
- 20220901
- Acronym
- RELAX
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuo X, Xu Y, Li S, Jiang J, Wang J, Zhu Y, Pan D, Li H, Chen Y, Chen Y, Rong X, Zheng D, Lu K, Mai H, Chen M, Chen P, Li J, Simone CB, Chua MLK, Li Y, Shen Q, Xiao S, Tang Y. Efficacy and safety of transcutaneous auricular vagus nerve stimulation plus pregabalin for radiotherapy-related neuropathic pain in patients with head and neck cancer (RELAX): a phase 2 randomised trial. EClinicalMedicine. 2025 Jul 12;86:103345. doi: 10.1016/j.eclinm.2025.103345. eCollection 2025 Aug.
PubMed 40697962Zuo X, Li Y, Rong X, Yang X, Zhu Y, Pan D, Li H, Shen QY, Tang Y. Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): protocol for a multicentre, randomised, double-blind, sham-controlled trial. BMJ Open. 2023 Sep 20;13(9):e072724. doi: 10.1136/bmjopen-2023-072724.
PubMed 37730386
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05543239
- Acronym / sponsor ID
- RELAX / 20220901
- Conditions
- Neuropathic Pain, Radiotherapy Side Effect
- Keywords
- Radiotherapy-Related Neuropathic Pain, Transcutaneous Auricular Vagus Nerve Stimulation, Head and Neck Cancers, Randomized controlled trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, randomized, double-blind, sham-controlled trial aims to investigate the effect and safety of TaVNS in treating radiotherapy-related neuropathic pain.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaVNS | Active comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)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. |
| Sham TaVNS | Sham comparator | Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged ≥18 years with an estimated survival of at least 5 months;
- Prior radiotherapy for histologically confirmed cancer ≥ 6 months prior to study entry;
- Pain for at least 4 weeks with an average intensity of ≥ 4 on an 11-point numeric rating scale (NRS) in the run-in period, and pain locations in accordance with radiated innervated areas, e.g. head, face, neck and arms;
- Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score ≥ 12 in the Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS) by two trained and experienced neurology specialists.
Key exclusion criteria (14 listed)
- Current diagnosis of tumor recurrence or metastasis and evidence of tumor-associated pain;
- Patients with non-radiotherapy induced neuropathic pain, e.g. postherpetic neuralgia, diabetes mellitus, HIV infection, spinal cord injury and other neurological disease;
- Use of carbamazepine, gabapentin, pregabalin, TaVNS or transcranial magnetic stimulation within the last 30 days prior to study entry;
- Other ongoing treatment for neuropathic pain, including antidepressants with norepinephrine and serotonin reuptake inhibition, calcium channel α2-δ ligands and other anticonvulsant medications, and topical lidocaine;
- Concomitant medication that may cause an adverse interaction with pregabalin, including sedative (e.g., benzodiazepines);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS)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. | Device | TaVNS |
| Sham Transcutaneous Auricular Vagus Nerve Stimulation(SS)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. | Device | Sham TaVNS |
Primary outcome
Change from baseline to day 7 with respect to pain intensity based on the NRS.
Time frame: Day 7
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".
8 secondary outcomes
Change from baseline to week 16 with respect to pain intensity based on the NRS.
Time frame: week 16
BPI-SF
Time frame: day 7, week 16
POMS-SF
Time frame: day 7, week 16
WHOQOL-BREF
Time frame: day 7, week 16
FACIT-F
Time frame: day 7, week 16
PGIC
Time frame: day 7, week 16
CGIC
Time frame: day 7, week 16
Serum Inflammatory Factors
Time frame: day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 40697962Zuo X, Xu Y, Li S, Jiang J, Wang J, Zhu Y, Pan D, Li H, Chen Y, Chen Y, Rong X, Zheng D, Lu K, Mai H, Chen M, Chen P, Li J, Simone CB, Chua MLK, Li Y, Shen Q, Xiao S, Tang Y. Efficacy and safety of transcutaneous auricular vagus nerve stimulation plus pregabalin for radiotherapy-related neuropathic pain in patients with head and neck cancer (RELAX): a phase 2 randomised trial. EClinicalMedicine. 2025 Jul 12;86:103345. doi: 10.1016/j.eclinm.2025.103345. eCollection 2025 Aug.
- Derived from this study: PubMed 37730386Zuo X, Li Y, Rong X, Yang X, Zhu Y, Pan D, Li H, Shen QY, Tang Y. Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): protocol for a multicentre, randomised, double-blind, sham-controlled trial. BMJ Open. 2023 Sep 20;13(9):e072724. doi: 10.1136/bmjopen-2023-072724.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yamei Tang, M.D.;PHD. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation(TaVNS) in people with Neuropathic Pain and Radiotherapy Side Effect, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang, M.D.;PHD. (+86-020-34070569, tangym@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to day 7 with respect to pain intensity based on the NRS. (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543239, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.