An interventional study of Sparrow Link (taVNS) in Chemotherapy Induced Peripheral Neuropathy (CIPN), sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
This purpose of this study is to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS) improves chemotherapy-induced peripheral neuropathy (CIPN) symptoms by assessing changes in daily symptom trajectories following treatment initiation. The study will also examine potential mechanisms of action through longitudinal assessment of inflammatory biomarkers, corticospinal excitability, and autonomic nervous system function.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's planned enrollment of 55 is close to the median of 52 across 831 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS). 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.
Device: Sparrow Link (taVNS)
Participants will self-administer transcutaneous auricular vagus nerve stimulation (taVNS) using the Sparrow Link portable stimulator and flexible ear electrodes for 1 hour daily for 14 days (total stimulation time: 14 hours).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.
Change in Daily Chemotherapy-Induced Peripheral Neuropathy Symptom Severity Measured by Numeric Rating Scale (NRS)
Participants will complete a daily electronic diary rating the severity of their most bothersome chemotherapy-induced peripheral neuropathy (CIPN) symptom (pain, numbness/tingling, burning, pressing/squeezing, or electric shocks) during the previous 24 hours using an 11-point Numeric Rating Scale (NRS), where 0 = no symptoms and 10 = worst imaginable symptoms. The primary analysis evaluates symptom trajectories using daily observations collected during the baseline and treatment periods.
Time frame: Baseline (Days -14 to 0), Treatment period (Day 1-14)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) is a validated 20-item questionnaire that assesses sensory, motor, and autonomic neuropathy symptoms. Responses are transformed to 0-100 subscale scores, with higher scores indicating greater symptom severity.
Time frame: Baseline (Day 0), Day 15, and Day 45 follow-up
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jun 2029, 29 months later.
Of 246 non-industry interventional studies with no phase under Neuralgia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 29 months is above that.
Counting every sponsor, half of 264 studies reached it within 24 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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