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Whiplash Associated Disorder (WAD)NCT07055373

Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders

A study testing Transauricular Vagal Nerve Stimulation in people with Whiplash Associated Disorder (WAD), run by University of Calgary at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Approximately 50% of people with chronic whiplash-associated disorders (WAD) continue to report the presence of symptoms 12 months post-injury. These symptoms include high levels of pain and disability as well as psychological symptoms such as post-traumatic stress. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Whiplash Associated Disorder (WAD)
What is being tested?
Transauricular Vagal Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteCanada
Study dates
21 Jan 2026to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptom duration ≥3 months and <10 years; and
  • Classifiable as WAD grade I (neck pain without physical impairments) or II (neck pain \& impairment such as movement loss and/or tenderness) or III (neck pain \& neurological deficit evident on physical exam);
  • Average pain intensity (over one week) ≥ 4/10;
  • Neck Disability Index score > 28% (14/50).

Who cannot join

  • WAD IV injury (no neurological deficit, fracture, or dislocation);
  • Concussion symptoms;
  • Patients who have undergone cervical vagotomy;
  • Patients diagnosed with severe bradycardia;
  • Patients with a permanent implanted metallic or electronic device or jewellery at close proximity to the ear tragus;
  • Patients with any active implanted device (including electronic and/or medical devices) e.g. cochlear implant, cerebral shunts, invasive vagus nerve stimulators, or non-active but potentially interacting with the nervous system (e.g., metal implants);
Show all 11Show fewer
  • Open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); or cancerous lesions in the area of stimulation
  • Using medications associated with ANS function such as Beta Blockers;
  • Adverse general health factors such as presence of a neurological disorder (e.g., multiple sclerosis), inflammatory condition (e.g., rheumatoid arthritis), cardiovascular disorder (known severe coronary disease or recent myocardial infarction (within 5 years)); metabolic disorder (e.g., diabetes), visual deficit or disease process (e.g. cataracts, double or blurred vision), known or suspected serious spinal pathology (e.g. metastatic disease of the spine), pregnancy, or previous spinal surgery or recurrent treatment for spinal disorders;
  • History of any mental health conditions prior to the MVC, such as bipolar disorder, schizophrenia, anxiety, PTSD or severe depression;
  • People who are unable to complete the questionnaires.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Laxshimalla contact

403-265-3838 ext. 2100

jennifer.laxshimalla@vivocura.ca

Canada1 site, 1 recruiting

  • Vivo Cura Health

    Calgary, Alberta, T2E 2P5

    Jennifer Laxshimalla, 403-265-3838 ext. 2100, jennifer.laxshimalla@vivocura.ca

    Ashley Smith

    Recruiting

Other trials in Canada

About this study

Official title: The Safety and Feasibility of Transauricular Vagus Nerve Stimulation Therapy in Chronic Whiplash-Associated Disorders: A Randomized Pilot Trial

Approximately 50% of people with chronic whiplash-associated disorders (WAD) continue to report the presence of symptoms 12 months post-injury. These symptoms include high levels of pain and disability as well as psychological symptoms such as post-traumatic stress. The nervous system may also be affected, specifically the autonomic nervous system which is responsible for regulating heart rate and blood pressure.

An important part of the autonomic system is the vagus nerve, which helps regulate pain and stress responses. Treatment of this nerve via transauricular vagal nerve stimulation (taVNS) has been shown to improve health outcomes in many pain conditions such as chronic low back pain and postural tachycardia syndrome. TaVNS works by sending mild electrical pulses through the ear.

This project aims to explore whether or not taVNS can help people with chronic whiplash-associated disorders (WAD) feel better. The first goal is to evaluate the safety and feasibility of taVNS. The investigators are interested in learning how many people with chronic WAD participate in the study and how many complete the full treatment, as well as ensuring that the treatment does not cause any serious side effects. An additional goal is to evaluate the effects of taVNS on neck pain intensity and associated disability, pain sensitivity, heart rate variability, blood pressure, quality of life, post-traumatic stress, stress, anxiety, and depression as measured by questionnaires and physical assessments, as compared to those assigned to the sham treatment.

Read the detailed description

Approximately 50% of people with chronic whiplash-associated disorders (WAD) continue to report the presence of symptoms 12 months post-injury. Many of these patients present with high levels of pain and disability and a heterogeneous presentation of both physical and psychological manifestations, inclusive of central nervous system hyperexcitability. Autonomic dysfunction has also been demonstrated in WAD.

Autonomic dysregulation via impaired peripheral vasoconstrictor responses has been demonstrated in both acute and chronic WAD, although the association with clinical features and health outcomes is unclear. Dysregulation of the hypothalamic-pituitary-adrenal axis (one of the key pathways to respond to stress) via reduced reactivity and enhanced negative feedback suppression has also been demonstrated in chronic WAD. In association with high levels of psychological distress and post-traumatic stress symptoms, stress system dysfunction in the form of autonomic nervous system (ANS) dysregulation is possible.

Previous resaerch by the investigators has demonstrated changes in autonomic function through heart rate and blood pressure measures in chronic WAD. More recently, the role of the ANS in chronic WAD has been examined using pupillometry. The results showed the presence of increased sympathetic nervous system activity, and reduced parasympathetic activity. These findings are consistent with those observed in other chronic pain conditions. This imbalance reportedly decreases the ANS adaptive response to both physical or emotional pain. These findings support the hypothesis that autonomic dysfunction potentially contributes to pain persistence.

An important link between the autonomic system and pain regulation mechanisms is the vagus nerve. Pain control occurs through vagally mediated afferent and efferent stimuli. The vagus nerve is also known to carry around 75% of parasympathetic fibers. Treatments affecting vagally mediated pain control includes non-invasive vagus nerve stimulation (VNS).

Transauricular VNS (taVNS) has been shown to improve health outcomes in many dysautonomic conditions and pain, such as chronic low back pain and postural tachycardia syndrome. Improvements in both biomarkers of autonomic dysfunction, such as heart rate variability (HRV); in association with reductions of pain and disability and improvements in pain sensitivity have been demonstrated, illustrating the potential of tVNS to modulate pain.

The specific objectives of this study are as follows:

  1. The primary objective is to evaluate the safety and feasibility of a randomized pilot study of taVNS as a treatment for patients with WAD in terms of recruitment (greater than 30%), attendance (70% total treatment time in a 4 week period), retention (greater than 70% complete protocol), safety (no severe adverse events and less than a 30% increase in adverse effects for the active group), and acceptability of the protocol.
  2. The secondary exploratory objectives are to evaluate neck pain intensity and associated disability, pain sensitivity, HRV, blood pressure, quality of life, post-traumatic stress, stress, anxiety, and depression - as measured by questionnaires and physical assessments - following active taVNS compared to sham taVNS in patients with WAD.

This will be a randomized, sham-controlled, participant and assessor blinded, pilot trial evaluating the safety and feasibility of taVNS for the treatment of WAD symptoms. Consenting and eligible participants will be asked to complete baseline questionnaires, physicial measurements (height, weight, and BMI), and clinical measurements. Questionnaires and physical measurements will be repeated immediately 1 month post taVNS and at 8-10 \& 16 weeks. Participants will be be asked to refrain from taking prescribed medications, performing physical exercise, or consuming alcohol or coffee on day of testing. Blood pressure, heart rate variability, and pupillary light reflex measures will be performed. Participants will be instructed on use of a taVNS device including precautions and safety information.

Following study enrolment, participants will be randomized into one of two groups: active taVNS or sham taVNS. Randomization will occur via a sealed envelope where participant numbers have been sorted into active or sham taVNS by a random number generator. Participants in the sham group will be blinded using a previously established blinding method. They will undergo a 30 second ramp up period, during which, the current will be gradually increased and then the machine will reduce the waveform to 0 whilst remaining in the 'on' mode. Assessors will be blinded to the participants grouping.

Transauricular VNS will be administered using the Nurosym aVNT (auricular vagal neuromodulation therapy) Device (Parasym, London, UK). The Nurosym aVNT Device delivers non-invasive neuromodulation targeting the auricular branch of the vagus nerve via the tragus of the outer ear. All participants will receive four weeks of twice daily (morning and evening) 45-minute sessions of taVNS (frequency ≥ 25Hz; pulse width =250µs.

Being tested
Transauricular Vagal Nerve Stimulation
Keywords
Whiplash Associated Disorder (WAD), Vagus Nerve Stimulation, Parasympathetic Nervous System, Sympathetic Nervous System, Post-traumatic Stress, Central Sensitization, Heart Rate Variability, Pupillometry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transauricular Vagal Nerve StimulationDevice

    Also called taVNS

    Transauricular VNS will be administered using the Parasym aVNT (auricular vagal neuromodulation therapy) Device (Nurosym, London, UK). The Parasym aVNT Device delivers non-invasive neuromodulation targeting the auricular branch of the vagus nerve via the tragus of the outer ear. All participants will receive four weeks of twice daily (morning and evening) 45-minute sessions of taVNS (frequency ≥ 25Hz; pulse width =250µs (Fig). The safety and tolerability of taVNS has been demonstrated in seven studies with a total of 205 (116 active, 121 sham) cardiovascular patients. Stimulation protocols ranged from 43 min to 8 hrs daily, for 1 day to 6 months. There were no device-related serious adverse events. Three patients (1.5%) experienced minor adverse events, i.e., dermal paresthesias (light tingling at the ear). No differences in tolerability were observed between active and sham taVNS [21].

Study groups in NCT07055373
Study groupRoleWhat they receive
Active Transauricular Vagal Nerve StimulationActive comparatorUpon enrolment, participants randomized into the active treatment arm will be asked to complete a series of questionnaires seeking information on physical measurements (height, weight, \& BMI), accident history, current symptoms, treatments received to date, and quality of life. Physical assessments will be performed to assess autonomic function and pain sensitivity including pupillary light reflex, heart rate variability, temporal summation, pressure pain thresholds, and conditioned pain modulation. Transauricular vagal nerve stimulation (taVNS) will be delivered a via a device that sends mild electrical pulses through the tragus of the outer ear. Participants will receive instructions device use in order to complete four weeks of twice daily (morning and evening) 45 minute sessions of taVNS. Follow ups will be completed immediately post intervention and at 4-6 weeks and 12 weeks 1 month post active taVNS. Participants will be asked to track device usage and report any adverse events.
Receives: Device: Transauricular Vagal Nerve Stimulation
Sham Transauricular Vagal Nerve StimulationSham comparatorParticipants assigned to the sham treatment arm will be asked to complete all the same questionnaires and physical assessments as those assigned to the active treatment arm. They will also be provided with a taVNS device and instructions on use. The device will be programed by the research team to reduce the output to '0' and thus those assigned to the sham group will not actually be receiving any active treatment. Participants will not be able to distinguish if any treatment is being received.
Receives: Device: Transauricular Vagal Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events (AEs); recruitment rate; attendance rate; retention rate.

    The primary objective is to evaluate the safety and feasibility of a randomized pilot study of taVNS as a treatment for patients with WAD in terms of recruitment (greater than 30%), attendance (70% total treatment time in a 4 week period), retention (greater than 70% complete protocol), safety (no severe adverse events and less than a 30% increase in adverse effects for the active group), and acceptability of the protocol.

    Measured: The study duration is 4 months, including 1 month of self-administered taVNS. Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

Secondary outcomes (10)

  1. Neck pain intensity as measured by the Numerical Pain Rating Scale, 0-10.

    Neck pain intensity will be measured via the Numerical Pain Rating Scale (NPRS). This scale ranges from 0-10 with a higher score indicating more pain intensity.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  2. Neck-related disability as measured by the Neck Disability Index, 0-50.

    Neck-related disability will be measure by the Neck Disability Index. This test ranges betweeen a score of 0-50 with higher scores meaning increased severity of neck-related disability.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  3. Pain sensitivity as measured by Pressure Pain Thresholds in Newtons.

    Changes in pain sensitivity will be measured by assessing presure pain thresholds. An algometer will be placed on the leg or neck region and pressure will be increased until the moment when the sensation of pressure first becomes painful. At this point, the pressure will stop being applied and the value will be recorded in Newtons.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  4. Temporal Summation as measured by NPRS, 0-10.

    Temporal summation will be measured using a pin prick. The pin prick will be gently raised and lowered over the hand region, without piercing the skin, to the beat of a metronome - 1 every second. The pain will be recorded at various times at different intervals by utilizing the Numerical Pain Rating Scale (NPRS) which ranges from 0-10.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  5. Sensitivity to pressure as measured by Conditioned Pain Modulation (% change from baseline).

    Sensitivity to pressure will be measured by Conditioned Pain Modulation (CPM). A blood pressure cuff will by worn on the upper arm and the pressure will be increased until the pain experienced is 5/10. At that time, pressure will also be applied to the shin to test the sensitivity in this region. The pressure pain threshold (PPT) on the shin will be compared before and during the arm pain from the cuff. The change in sensitivity will be recorded as a percentage of the baseline value. A lower pressure senstivity during the cuff main indicates suggests better pain tolerance. Pain inhibition is indicated if the percentage is negative.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  6. Heart rate variability (RMSSD in ms).

    Heart rate variability (HRV) will be measured via HRV4Training app and the root mean square of successive differences (RMSSD) will be recorded in ms. RMSSD is a measure of HRV which calculats the variability of the heart rate in one minute.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  7. Blood pressure recorded in mmHg.

    Blood pressure will be recorded while seated using a standard arm cuff (sphygmomanometer).

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  8. Quality of life as measured by SF-12.

    Quality of life will be evaluated using the Short Form-12 (SF-12) questionnaire which measures both a physical component summary (PCS0) and mental component summary (MCS) score. Higher scores reflect better health status.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  9. PTSD symptoms as measured by the PCL-5.

    PTSD symptoms will be assesed using the PCL-5 questionnaire. This questionnaire consists of 20 questions reflecting DSM-5 PTSD criteria. The answer to each question is rated 0-4 with the total score ranging from 0-20. Higher scores indicated increased PTSD symptom severity.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

  10. Depression, anxiety, and stress via DASS-21.

    Changes in depression, anxiety, and stress will be measured using the DASS-21 questionniare consisting of 21 questions measuring symptoms of each condition. Each question can be rated on a 4-point Likert scale. Scores for each of the three subscales (7 questions each) are summed and multiplied by 2 to give a final score for each condition ranging from 0-42. Higher scores indicated increased symptom severity for each condition.

    Measured: Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start21 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07055373
Sponsor's protocol ID
REB25-0529
Status last verified
Apr 2026
First submitted
9 Jun 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bouma C, Smith AD. The relationship between pupillary light reflex and clinical measures of central pain processing in chronic WAD. An observational study with healthy cohort comparison. Musculoskelet Sci Pract. 2026 Aug 25;86:103643. doi: 10.1016/j.msksp.2026.103643. Online ahead of print.

    PubMed 42679631

  • Tracy LM, Ioannou L, Baker KS, Gibson SJ, Georgiou-Karistianis N, Giummarra MJ. Meta-analytic evidence for decreased heart rate variability in chronic pain implicating parasympathetic nervous system dysregulation. Pain. 2016 Jan;157(1):7-29. doi: 10.1097/j.pain.0000000000000360.

    PubMed 26431423

  • Forte G, Troisi G, Pazzaglia M, Pascalis V, Casagrande M. Heart Rate Variability and Pain: A Systematic Review. Brain Sci. 2022 Jan 24;12(2):153. doi: 10.3390/brainsci12020153.

    PubMed 35203917

  • Koenig J, Falvay D, Clamor A, Wagner J, Jarczok MN, Ellis RJ, Weber C, Thayer JF. Pneumogastric (Vagus) Nerve Activity Indexed by Heart Rate Variability in Chronic Pain Patients Compared to Healthy Controls: A Systematic Review and Meta-Analysis. Pain Physician. 2016 Jan;19(1):E55-78.

    PubMed 26752494

  • Gockel M, Lindholm H, Niemisto L, Hurri H. Perceived disability but not pain is connected with autonomic nervous function among patients with chronic low back pain. J Rehabil Med. 2008 May;40(5):355-8. doi: 10.2340/16501977-0172.

    PubMed 18461260

  • Meints SM, Garcia RG, Schuman-Olivier Z, Datko M, Desbordes G, Cornelius M, Edwards RR, Napadow V. The Effects of Combined Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation and Mindfulness Meditation for Chronic Low Back Pain: A Pilot Study. Pain Med. 2022 Aug 31;23(9):1570-1581. doi: 10.1093/pm/pnac025.

    PubMed 35148407

  • Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA, Szeles JC, Finster G, Schiesser AW, Heinze G, Kress HG. The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg. 2004 May;98(5):1359-64, table of contents. doi: 10.1213/01.ane.0000107941.16173.f7.

    PubMed 15105215

  • Stavrakis S, Chakraborty P, Farhat K, Whyte S, Morris L, Abideen Asad ZU, Karfonta B, Anjum J, Matlock HG, Cai X, Yu X. Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. JACC Clin Electrophysiol. 2024 Feb;10(2):346-355. doi: 10.1016/j.jacep.2023.10.015. Epub 2023 Nov 22.

    PubMed 37999672

  • Geng D, Liu X, Wang Y, Wang J. The effect of transcutaneous auricular vagus nerve stimulation on HRV in healthy young people. PLoS One. 2022 Feb 10;17(2):e0263833. doi: 10.1371/journal.pone.0263833. eCollection 2022.

    PubMed 35143576

  • Uzlifatin Y, Arfianti L, Wardhani IL, Hidayati HB, Melaniani S. Effect of transcutaneous auricular vagus nerve stimulation in addition to exercises on disabilitiy in chronic low back pain patients: A randomized controlled study. Anaesth Pain Intensive Care 2023; 21(1):73-81.

  • Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

    PubMed 23295957

  • Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine (Phila Pa 1976). 1995 Apr 15;20(8 Suppl):1S-73S. No abstract available.

    PubMed 7604354

  • Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005;4(4):287-291.

  • Luche G, Dundovic S, Stavrakis S. REPORT OF SAFETY AND TOLERABILITY OF LOW-LEVEL TRAGUS VAGAL NEUROMODULATION IN CARDIOVASCULAR PATIENTS. JACC 2024;83:13:178.

  • Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.

    PubMed 19418100

Questions about this trial

What is this clinical trial studying?

A study testing Transauricular Vagal Nerve Stimulation in people with Whiplash Associated Disorder (WAD), run by University of Calgary at 1 site in Canada.

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 11 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Laxshimalla (403-265-3838 ext. 2100, jennifer.laxshimalla@vivocura.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events (AEs); recruitment rate; attendance rate; retention rate. (time frame: The study duration is 4 months, including 1 month of self-administered taVNS. Outcome measures will be assessed at baseline, immediately post-treatment (end of week 4) and during follow-ups at Week 8-10 and Week 16.). 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 NCT07055373, which also lists 38 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 1 May 2026.

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