Self-applied taVNS for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
This study is exploring a portable device called transcutaneous auricular vagus nerve stimulation (taVNS) for people with chemotherapy-induced peripheral neuropathy (CIPN). CIPN is nerve damage that can cause pain, tingling, or numbness after chemotherapy. The taVNS device has small electrodes that you place on your outer ear to deliver a mild electrical stimulation to the vagus nerve. The main goal is to see if it's practical for people to use this device at home daily for two weeks. You might be able to join if you are 18-80 years old, have had platinum or taxane chemotherapy, and have had CIPN symptoms for at least 3 months with pain of 4/10 or more in the last week. The study plans to enroll 36 participants, and the current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 36 participants. Participants with CIPN will be in an intervention group (n=24) and will self-apply taVNS daily.
- What's involved
- If you have CIPN, you will complete a 2-week trial of daily self-applied taVNS. Your retention in the study will be measured at baseline, day 7, day 14, and a 28-day follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your retention in the study will be measured at baseline, day 7, day 14, and a 28-day follow-up.
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Self-applied taVNS for CIPN
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Marlon L Marlon, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Retention Rate (taVNS Intervention Cohort)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)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)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)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)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.