Trial of Self-Applied Transcutaneous Auricular Vagus Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy
Single-Arm Bayesian Phase II Trial of Self-Applied Transcutaneous Auricular Vagus Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Marlon L Wong, PT, PhD
- E-post: mwong2@miami.edu
Studera Kontakt Backup
- Namn: Richard A Martinez, MS
- Telefonnummer: 3052842359
- E-post: rxm1388@med.miami.edu
Studieorter
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- Christine E Lynn Rehabilitation Center
-
Kontakt:
- Marlon L Wong, PT, PhD
- E-post: mwong2@miami.edu
-
Kontakt:
- Richard A Martinez, MS
- Telefonnummer: 3052842359
- E-post: rxm1388@miami.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age 18-80 years
- Prior exposure to platinum, taxane, or vinca alkaloid chemotherapy
- Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy
- Worst CIPN-related symptom ≥4/10 over the last week
Exclusion Criteria:
- 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 (i.e, tumor resection, radiation therapy, and/or taxane/platinum/vinca alkaloid chemotherapy treatments. Maintenance therapies, including hormonal therapy or Poly (ADP-ribose) Polymerase (PARP) inhibitors, are allowed and not part of exclusion criteria. Patients may have pending reconstructive surgeries planned as long as it is planned outside of the study participation window.)
- Metal implants in the head or neck (e.g., cochlear implant)
- Implanted electronic or magnetic devices (e.g., pacemaker, medication pumps, other implanted neurostimulation systems)
- Known allergy to tape/adhesives
- History of seizure/epilepsy, intracranial pathology, or other neurological condition associated with increased seizure risk
- Pregnancy or actively breast feeding
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Auricular Vagus Nerve (AVNS) Group
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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Daily Chemotherapy-Induced Peripheral Neuropathy Symptom Severity Measured by Numeric Rating Scale (NRS)
Tidsram: Baseline (Days -14 to 0), Treatment period (Day 1-14)
|
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. |
Baseline (Days -14 to 0), Treatment period (Day 1-14)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20)
Tidsram: Baseline (Day 0), Day 15, and Day 45 follow-up
|
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. |
Baseline (Day 0), Day 15, and Day 45 follow-up
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Marlon L Wong, PT, PhD, University of Miami
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20260819
Plan för individuella deltagardata (IPD)
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