Self-applied taVNS for CIPN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov