Chemotherapy Induced Peripheral NeuropathyNCT07596030
Self-applied taVNS for CIPN
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Chemotherapy Induced Peripheral Neuropathy, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chemotherapy-induced peripheral neuropathy (CIPN) group:
- Age 18-80 years
- Prior exposure to platinum or taxane chemotherapy
- Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy
- Worst CIPN-related pain ≥4/10 over the last week
- Registry Cohort:
Show all 9Show fewer
- Age 18-80 years
- Prior exposure to platinum or taxane chemotherapy
- Denis any current neuropathic symptoms as described above.
Who cannot join
- All participants:
- Unstable cardiac disease/ Known arrhythmias
- Head or neck cancer or metastases
- Recent ear trauma or active dermatologic disease at the stimulation site
- <2 months since completion of cancer treatment or surgery
- Metal implants in the head or neck (e.g., cochlear implant)
Show all 10Show fewer
- Implanted electronic devices (e.g., pacemaker)
- Known allergy to tape/adhesives
- History of seizure/epilepsy, intracranial pathology, or skull defect
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami, Plumer Building
Coral Gables, Florida, 33146
Richard L. Martinez, MSPH, 305-284-2359, rxm1388@med.miami.edu
Marlon L Wong, PT, PhD, mwong2@miami.edu
About this study
Official title: Feasibility of Self-Applied Vagus Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy
The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. This device delivers a mild electrical stimulation to the vagus nerve through the ear. This study will explore how taVNS may affect symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of two cohorts based on the presence of chemotherapy-induced peripheral neuropathy (CIPN). Participants with CIPN will be placed in the intervention cohort (n=24) and will complete a 2-week trial of daily self-applied taVNS. Participants without CIPN will be placed in the registry cohort (n=12) and will complete study measurements without receiving the intervention. The registry cohort will not receive the taVNS intervention but will undergo identical physiological assessments at baseline and at a 2 week follow up to control for testing effects and biological variability.
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Keywords
- vagus nerve stimulation, peripheral neuropathy, heart rate variability, transcranial magnetic stimulation
- Medical subject headings
- Peripheral Nervous System Diseases
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
A portable taVNS Stimulator (Soterix Medical) will be used with flexible electrodes to administer taVNS near areas surrounding the ear. Each stimulation session will last approximately 60 minutes at monophasic pulses.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Intervention Cohort | Experimental | Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS) for chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will use a portable taVNS device at home once daily for 14 consecutive days, applying stimulation to the auricular vagus nerve according to standardized instructions provided by the study team. Each stimulation session will last approximately 60 minutes at monophasic pulses. The treatment stimulation intensity can be increased up to 5mA, but this will be adjusted for each participant to ensure it is below the pain threshold. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| No intervention (Prospective Registry Cohort) | No intervention | Participants in this group will not receive an intervention. This group consists of a prospective registry cohort of cancer survivors with prior taxane or platinum exposure who did not develop chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will be enrolled into the registry for classification and observational comparison purposes only. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day registry period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate (taVNS Intervention Cohort)
Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.
Measured: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Retention Rate (Prospective Registry Cohort)
Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.
Measured: Baseline (Day 0 (T0) and Day 14 (T2)
Recruitment Rate (taVNS Intervention Cohort)
Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study.
Measured: Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months)
Acceptability (taVNS Intervention Cohort)
Acceptability will be measured as the percentage of participants reporting overall acceptable or satisfactory experiences with the intervention during exit interviews. Acceptability will be considered successful if ≥ 80% of participants provide favorable responses.
Measured: Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0)
Treatment Adherence (taVNS Intervention Cohort)
Treatment adherence will be assessed using the unique device-generated code associated with each taVNS session. Adherence will be considered successful if participants complete ≥ 80% of planned sessions as documented by device-logged session codes. Adherence will be calculated as: Number of completed session codes ÷ Number of programmed session codes) × 100 over the 14-day treatment period.
Measured: 14 days of intervention
Secondary outcomes (8)
Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort)
The EORTC quality of life questionnaire (CIPN20), will be used to assess CIPN symptoms over the past week. The CIPN20 is widely used in research and in clinical practice to assess pain CIPN symptoms using a 20-item validated questionnaire measuring sensory, motor, and autonomic neuropathy symptoms. Scores are transformed to 0-100 subscale scores according to the EORTC scoring manual, with higher scores indicating greater symptom severity.
Measured: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Change in Neuropathic Pain Intensity (Numeric Pain Rating Scale) (taVNS Intervention Cohort)
Neuropathic pain intensity will be assessed using the 0-10 Numeric Pain Rating Scale (NPRS). Participants will rate their worst pain over the past week on a scale from 0 (no pain) to 10 (worst imaginable pain). The NPRS is widely used in research and in clinical practice to assess nonpainful CIPN symptoms.
Measured: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Change in Serum Neurofilament Light Chain (NfL)
Change in serum neurofilament light chain (NfL) concentrations (picograms per milliliter [pg/mL]) will be calculated as the difference between values obtained at baseline (Day 0 [T0]) and Day 14 (T2).
Measured: Baseline (Day 0 (T0), to Day 14 (T2)
Change in Serum Interleukin-1 Beta (IL-1β)
Change in serum interleukin-1 beta (IL-1β) concentrations (picograms per milliliter [pg/mL]) will be calculated as the difference between values obtained at baseline (Day 0) and Day 14.
Measured: Baseline (Day 0 (T0) to Day 14 (T2)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
Change in serum tumor necrosis factor-alpha (TNF-α) concentrations (picograms per milliliter [pg/mL]) will be calculated as the difference between values obtained at baseline (Day 0) and Day 14.
Measured: Baseline (Day 0 (T0) to Day 14 (T2)
Change in Serum Interleukin-6 (IL-6)
Change in serum interleukin-6 (IL-6) concentrations (picograms per milliliter [pg/mL]) will be calculated as the difference between values obtained at baseline (Day 0) and Day 14 .
Measured: Baseline (Day 0, (T0) to Day 14 (T2)
Change in SICI (neurophysiological measure of corticospinal excitability)
Change in short-interval intracortical inhibition (SICI), will be calculated as the difference between values obtained at baseline (Day 0) and Day 14. SICI will be expressed as the ratio or percentage (%) of conditioned motor evoked potential (MEP) amplitude relative to unconditioned MEP amplitude.
Measured: Baseline (Day 0 (T0) to Day 14 (T2)
Change in Heart rate variability (HRV, surrogate measure of autonomic balance)
Change in heart rate variability (HRV), will be calculated as the difference between values obtained at baseline (Day 0) and Day 14 reported in milliseconds (ms).
Measured: Baseline (Day 0 (T0) to Day 14 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start2 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a parallel-cohort design comprising two distinct components: Interventional Feasibility Cohort 1: (n=24): Feasibility interventional cohort of self-applied taVNS in cancer survivors with chronic CIPN. Prospective Registry Cohort 2: (n=12): An observational, non-interventional comparator cohort of cancer survivors with similar taxane/platinum exposure who did not develop chronic CIPN.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlon Wong, University of Miami
- Investigators
- Marlon L Marlon, PT, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596030
- Sponsor's protocol ID
- 20260068
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Self-Applied Vagus Nerve Stimulation for Chemotherapy Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07596030
- Acronym / sponsor ID
- 20260068
- Keywords
- vagus nerve stimulation, peripheral neuropathy, heart rate variability, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 May 2026 (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.
The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. This device delivers a mild electrical stimulation to the vagus nerve through the ear. This study will explore how taVNS may affect symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of two cohorts based on the presence of chemotherapy-induced peripheral neuropathy (CIPN). Participants with CIPN will be placed in the intervention cohort (n=24) and will complete a 2-week trial of daily self-applied taVNS. Participants without CIPN will be placed in the registry cohort (n=12) and will complete study measurements without receiving the intervention. The registry cohort will not receive the taVNS intervention but will undergo identical physiological assessments at baseline and at a 2 week follow up to control for testing effects and biological variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study utilizes a parallel-cohort design comprising two distinct components: Interventional Feasibility Cohort 1: (n=24): Feasibility interventional cohort of self-applied taVNS in cancer survivors with chronic CIPN. Prospective Registry Cohort 2: (n=12): An observational, non-interventional comparator cohort of cancer survivors with similar taxane/platinum exposure who did not develop chronic CIPN.
| Arm | Type | Receives |
|---|---|---|
| taVNS Intervention Cohort | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS) for chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will use a portable taVNS device at home once daily for 14 consecutive days, applying stimulation to the auricular vagus nerve according to standardized instructions provided by the study team. Each stimulation session will last approximately 60 minutes at monophasic pulses. The treatment stimulation intensity can be increased up to 5mA, but this will be adjusted for each participant to ensure it is below the pain threshold. |
| No intervention (Prospective Registry Cohort) | No intervention | –Participants in this group will not receive an intervention. This group consists of a prospective registry cohort of cancer survivors with prior taxane or platinum exposure who did not develop chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will be enrolled into the registry for classification and observational comparison purposes only. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day registry period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-80 years
- Prior exposure to platinum or taxane chemotherapy
- Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy
- Worst CIPN-related pain ≥4/10 over the last week
- Age 18-80 years
Key exclusion criteria (10 listed)
- Unstable cardiac disease/ Known arrhythmias
- Head or neck cancer or metastases
- Recent ear trauma or active dermatologic disease at the stimulation site
- <2 months since completion of cancer treatment or surgery
- Metal implants in the head or neck (e.g., cochlear implant)
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)A portable taVNS Stimulator (Soterix Medical) will be used with flexible electrodes to administer taVNS near areas surrounding the ear. Each stimulation session will last approximately 60 minutes at monophasic pulses. | Device | taVNS Intervention Cohort |
Primary outcome
Retention Rate (taVNS Intervention Cohort)
Time frame: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.
Retention Rate (Prospective Registry Cohort)
Time frame: Baseline (Day 0 (T0) and Day 14 (T2)
Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study.
Recruitment Rate (taVNS Intervention Cohort)
Time frame: Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months)
Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study.
Acceptability (taVNS Intervention Cohort)
Time frame: Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0)
Acceptability will be measured as the percentage of participants reporting overall acceptable or satisfactory experiences with the intervention during exit interviews. Acceptability will be considered successful if ≥ 80% of participants provide favorable responses.
Treatment Adherence (taVNS Intervention Cohort)
Time frame: 14 days of intervention
Treatment adherence will be assessed using the unique device-generated code associated with each taVNS session. Adherence will be considered successful if participants complete ≥ 80% of planned sessions as documented by device-logged session codes. Adherence will be calculated as: Number of completed session codes ÷ Number of programmed session codes) × 100 over the 14-day treatment period.
8 secondary outcomes
Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort)
Time frame: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Change in Neuropathic Pain Intensity (Numeric Pain Rating Scale) (taVNS Intervention Cohort)
Time frame: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)
Change in Serum Neurofilament Light Chain (NfL)
Time frame: Baseline (Day 0 (T0), to Day 14 (T2)
Change in Serum Interleukin-1 Beta (IL-1β)
Time frame: Baseline (Day 0 (T0) to Day 14 (T2)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
Time frame: Baseline (Day 0 (T0) to Day 14 (T2)
Change in Serum Interleukin-6 (IL-6)
Time frame: Baseline (Day 0, (T0) to Day 14 (T2)
Change in SICI (neurophysiological measure of corticospinal excitability)
Time frame: Baseline (Day 0 (T0) to Day 14 (T2)
Change in Heart rate variability (HRV, surrogate measure of autonomic balance)
Time frame: Baseline (Day 0 (T0) to Day 14 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- 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.
Marlon L Marlon, PT, PhD principal investigator
University of Miami
1 site 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 Chemotherapy Induced Peripheral Neuropathy, run by University of Miami at 1 site in United States.
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 9 inclusion and 10 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 26 Jun 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 United States. 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. 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 Richard L Martinez, MSPH (3052842359, rxm1388@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (taVNS Intervention Cohort) (time frame: Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.