NCT07596030 · University of Miami
Self-applied taVNS for CIPN
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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:
- Age 18-80 years
- Prior exposure to platinum or taxane chemotherapy
- Denis any current neuropathic symptoms as described above.
Exclusion criteria
- 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)
- Implanted electronic devices (e.g., pacemaker)
- Known allergy to tape/adhesives
- History of seizure/epilepsy, intracranial pathology, or skull defect
Where
- Coral Gables, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations