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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
DeviceA 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: taVNS Intervention CohortExperimental treatment 1 intervention
Group B: No intervention (Prospective Registry Cohort)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)2
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.
Time frame
Baseline (Day 0 (T0) and Day 14 (T2)3
Recruitment Rate (taVNS Intervention Cohort)
Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study.
Time frame
Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months)4
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.
Time frame
Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0)Secondary outcomes
1
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.
Time frame
Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)2
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.
Time frame
Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3)3
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).
Time frame
Baseline (Day 0 (T0), to Day 14 (T2)4
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.
Time frame
Baseline (Day 0 (T0) to Day 14 (T2)Sponsors and contacts
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Source ClinicalTrials.gov