- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07680127
TENS of Auricular Vagal Nerve for Radiation Necrosis
1 september 2026 uppdaterad av: Virginia Commonwealth University
Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis
This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema.
In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2).
Patients in both arms will have imaging performed and tissue and blood collected for assessment of changes in area of contrast enhancement and cerebral edema, inflammatory markers, and markers of blood-brain barrier permeability.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Amy Erickson
- Telefonnummer: 804-828-9165
- E-post: amy.erickson@vcuhealth.org
Studieorter
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
-
Kontakt:
- Amy Erickson
- Telefonnummer: 804-828-9165
- E-post: amy.erickson@vcuhealth.org
-
Huvudutredare:
- Ryan Cleary, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- History of glioma or metastatic brain lesion previously treated with whole brain radiation, stereotactic radiation surgery, or fractionated radiation therapy
- Magnetic resonance imaging (MRI) findings consistent with possible radiation necrosis within 6 weeks prior to enrollment.
- Candidate for tissue biopsy and Laser Interstitial Thermal Therapy (LITT) ablation of the lesion
- At least 18 years of age
- If on corticosteroids, able to discontinue at least 5 days prior to start of transcutaneous auricular vagus nerve stimulation (taVNS) (Arm 1) or sham treatment (Arm 2). A stable physiologic dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the investigator. 6. Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
- New onset neurologic deficits secondary to radiation necrosis requiring initiation of dexamethasone therapy or other intervention prior to enrollment
- Currently receiving bevacizumab for treatment of radiation necrosis or has received bevacizumab < 6 weeks prior to study enrollment.
- Currently receiving any investigational agents for treatment of radiation necrosis or has participated in a study of an investigational agent for radiation necrosis within 3 weeks prior to study enrollment.
- History of cardiac conduction disorders or presence of implanted electronic devices
- Active Crohn's disease or other inflammatory bowel disease.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Sham Comparator: Bluff
|
TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear, with no stimulation twice daily for 12 to 14 days prior to planned LITT ablation.
|
|
Experimentell: Transkutan Auricular Vagal Nerve Stimulering (taVNS)
|
Transcutaneous auricular vagal nerve stimulation (taVNS) stimulation twice daily for 12 to 14 days prior to planned LITT ablation via TENS (transcutaneous electrical nerve stimulation) unit connected to an earpiece that fits into the concha of the ear.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assess changes in the serum inflammatory marker Tumor Necrosis Factor (TNF)-alpha
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker TNF-alpha utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assess changes in serum inflammatory marker Interleukin 12 (IL-12)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in (IL-12) serum inflammatory marker utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker granulocyte-macrophage colony-stimulating factor (GMCSF)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker GMCSF utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker Interferon gamma (IFN gamma)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IFN gamma utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 1 beta (IL-1b)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-1b utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin-10 (IL-10)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-10 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 13 (IL-13)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-13 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin (IL-2)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-2 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory markers interleukin 17 (IL-17A)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-17A utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 4 (IL-4)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory marker IL-4 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 5 (IL-5)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-5 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 6 (IL-6)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-6 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in serum inflammatory marker interleukin 8 (IL-8)
Tidsram: Baseline, 1 week, and 2 weeks following intervention
|
Percent change in serum inflammatory markers IL-8 utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, 1 week, and 2 weeks following intervention
|
|
Assess changes in biomarker Neurofilament light chain (NFL) of central nervous system (CNS) injury following treatment
Tidsram: Baseline, and 2 weeks following intervention
|
Percent change of NFL marker of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
|
Assess changes in biomarker platelet-derived growth factor receptor-beta (PDGFR-beta) of central nervous system (CNS) injury following treatment
Tidsram: Baseline, and 2 weeks following intervention
|
Percent change of marker PDGFR-beta of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
|
Assess changes in biomarker vascular endothelial growth factor (VEGF) of central nervous system (CNS) injury following treatment
Tidsram: Baseline, and 2 weeks following intervention
|
Percent change of marker VEGF of CNS inflammation utilizing serum inflammatory marker analysis from collected blood samples
|
Baseline, and 2 weeks following intervention
|
|
Assess changes in biomarkers of blood-brain barrier (BBB) permeability following treatment
Tidsram: Baseline, and 2 weeks following intervention
|
Percent change of BBB permeability
|
Baseline, and 2 weeks following intervention
|
|
Assess interval changes in radiation necrosis on MRI after treatment w taVNS
Tidsram: Baseline, and 2 weeks following intervention
|
Percent changes in areas of contrast enhancement and perilesional T2-weighted fluid-attenuated inversion recovery (T2/FLAIR) Hypersensitivity on magnetic resonance imaging (MRI).
On these images, areas with higher water content suck as edema, inflammation, or demyelination, appear brighter compared to surrounding tissue.
|
Baseline, and 2 weeks following intervention
|
|
Assess interval changes in cerebral edema on MRI after treatment
Tidsram: Baseline, and 2 weeks following intervention
|
Percent changes in areas of contrast enhancement and perilesional T2/FLAIR Hypersensitivity on MRI
|
Baseline, and 2 weeks following intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ryan Cleary, MD, Virginia Commonwealth University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 november 2026
Primärt slutförande (Beräknad)
31 augusti 2029
Avslutad studie (Beräknad)
31 augusti 2029
Studieregistreringsdatum
Först inskickad
25 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
2 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MCC-25-22821
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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