Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:02 PM
Study NCT ID:
NCT05243303
Status:
RECRUITING
Last Update Posted:
2023-07-10
First Post:
2022-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients in both arms will not know in which of the two arms (active treatment or control group) they are randomized. The sham procedure is similar to the transcutaneous auricular vagus nerve stimulation (but does not involve the actual stimulation). Therefore, it is unlikely that patients are able to differentiate whether they are assigned to the control group or to the active treatment group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with plaque psoriasis will be randomized in one of two groups: (1) Active treatment group. These patients will receive daily transcutaneous auricular vagus nerve stimulation for 3 months; (2) Control group. These patients will receive a sham procedure instead of the transcutaneous auricular vagus nerve stimulation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-02-14', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Psoriasis Area and Severity Index from Baseline at 1 Week', 'timeFrame': 'After 1 week of treatment.', 'description': 'Clinical assessment of the severity of plaque psoriasis'}, {'measure': 'Change in Psoriasis Area and Severity Index from Baseline at 1 Month', 'timeFrame': 'After 1 month of treatment.', 'description': 'Clinical assessment of the severity of plaque psoriasis'}, {'measure': 'Change in Psoriasis Area and Severity Index from Baseline at 2 Months', 'timeFrame': 'After 2 months of treatment.', 'description': 'Clinical assessment of the severity of plaque psoriasis'}, {'measure': 'Change in Psoriasis Area and Severity Index from Baseline at 3 Months', 'timeFrame': 'After 3 months of treatment.', 'description': 'Clinical assessment of the severity of plaque psoriasis'}], 'secondaryOutcomes': [{'measure': 'Change in Heart Rate Variability from Baseline at 1 Week', 'timeFrame': 'After 1 week of treatment.', 'description': 'Heart rate variability will be determined from ECG recordings'}, {'measure': 'Change in Heart Rate Variability from Baseline at 1 Month', 'timeFrame': 'After 1 month of treatment.', 'description': 'Heart rate variability will be determined from ECG recordings'}, {'measure': 'Change in Heart Rate Variability from Baseline at 2 Months', 'timeFrame': 'After 2 months of treatment.', 'description': 'Heart rate variability will be determined from ECG recordings'}, {'measure': 'Change in Heart Rate Variability from Baseline at 3 Months', 'timeFrame': 'After 3 months of treatment.', 'description': 'Heart rate variability will be determined from ECG recordings'}, {'measure': 'Change in Plasma Cytokine Levels from Baseline at 1 Week', 'timeFrame': 'After 1 week of treatment.', 'description': 'Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.'}, {'measure': 'Change in Plasma Cytokine Levels from Baseline at 1 Month', 'timeFrame': 'After 1 month of treatment.', 'description': 'Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.'}, {'measure': 'Change in Plasma Cytokine Levels from Baseline at 2 Months', 'timeFrame': 'After 2 months of treatment.', 'description': 'Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.'}, {'measure': 'Change in Plasma Cytokine Levels from Baseline at 3 Months', 'timeFrame': 'After 3 months of treatment.', 'description': 'Plasma concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be determined from blood samples.'}, {'measure': 'Change from baseline in cytokine release from cultured leukocytes at 1 week', 'timeFrame': 'After 1 week of treatment.', 'description': 'Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.'}, {'measure': 'Change from baseline in cytokine release from cultured leukocytes at 1 month', 'timeFrame': 'After 1 month of treatment.', 'description': 'Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.'}, {'measure': 'Change from baseline in cytokine release from cultured leukocytes at 2 months', 'timeFrame': 'After 2 months of treatment.', 'description': 'Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.'}, {'measure': 'Change from baseline in cytokine release from cultured leukocytes at 3 months', 'timeFrame': 'After 3 months of treatment.', 'description': 'Cytokine concentrations (pg/mL) for 8 different cytokines (GM CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, and TNF-α) will be measured in supernatant from LPS-stimulated leukocyte cultures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transcutaneous auricular vagus nerve stimulation', 'inflammation'], 'conditions': ['Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'The human body responds to inflammation, such as psoriatic skin lesions, by activating the cholinergic anti-inflammatory pathway. In patients with plaque psoriasis, this pathway is not sufficient to clear the skin lesions. Importantly, the vagus nerve, that is part of the anti-inflammatory pathway, also innervates the ear where it can be activated through non-invasive transcutaneous auricular vagus nerve stimulation (taVNS). This raises the research question if taVNS - added to standard of care - improves the symptoms of plaque psoriasis by augmenting the function of the cholinergic anti-inflammatory pathway. Thus, the aim of this project is to test the hypothesis that daily taVNS applied for 3 months results in anti-inflammatory actions and improvements in the Psoriasis Area and Severity Index (PASI). Potential anti-inflammatory actions of taVNS compared to a sham-taVNS control group will be assessed by plasma cytokine levels, flow cytometry, and cell culture experiments. This project is potentially significant, because it may demonstrate that taVNS lessens the symptoms of plaque psoriasis and, therefore, improves the quality of life of millions of patients.', 'detailedDescription': "An estimated 20% of psoriasis patients experience treatment failure. Afferent vagal nerve fibers that are part of the anti-inflammatory reflex sense inflammation, such as psoriatic skin lesions. The investigators' pilot data show that transcutaneous auricular vagus nerve stimulation (taVNS) activates afferent nerve fibers within the auricular branch of the vagus nerve to trigger anti-inflammatory reflex responses in healthy individuals. However, it is unknown if taVNS improves plaque psoriasis through the anti-inflammatory reflex. The lack of studies on taVNS in plaque psoriasis constitutes a missed opportunity to reduce treatment failures.\n\nThe long-term goal of this research is to establish a neuromodulatory approach to activate the anti-inflammatory reflex in patients with plaque psoriasis to lessen treatment failures. The objective of this study is to test the hypothesis that taVNS elicits anti-inflammatory reflex responses and reduces the severity of plaque psoriasis.\n\nIn a single-blinded randomized controlled clinical trial, participants will self-administer taVNS or sham-taVNS (control) daily for a duration of 3 months, while continuing their standard-of-care treatment. At baseline, 7 days, and 1, 2, and 3 months, clinical , autonomic, and inflammatory responses will be assessed.\n\nAt the conclusion of this study, the investigators expect to demonstrate anti-inflammatory reflex responses to taVNS and reduced severity of plaque psoriasis. These outcomes are expected to have important positive impact, because they are anticipated to reduce treatment failures in patients with plaque psoriasis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Plaque psoriasis diagnosed by a dermatologist\n\nExclusion Criteria:\n\n* pregnancy\n* vestibulocochlear neuronitis or nerve damage\n* cardiac arrhythmia\n* epilepsy\n* anticipated change in medication during the 3-month study period'}, 'identificationModule': {'nctId': 'NCT05243303', 'briefTitle': 'Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation', 'organization': {'class': 'OTHER', 'fullName': 'Burrell College of Osteopathic Medicine'}, 'officialTitle': 'Augmenting Standard-of-care Treatment of Plaque Psoriasis by Neuromodulation', 'orgStudyIdInfo': {'id': '0090_2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active taVNS', 'description': 'These patients will self-administer transcutaneous auricular vagus nerve stimulation (taVNS).', 'interventionNames': ['Device: Active taVNS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham taVNS', 'description': 'These patients will self-administer a sham procedure mimicking the active taVNS procedure.', 'interventionNames': ['Device: Sham taVNS']}], 'interventions': [{'name': 'Active taVNS', 'type': 'DEVICE', 'otherNames': ['active transcutaneous auricular vagus nerve stimulation'], 'description': 'A bipolar clip electrode is placed at the cymba conchae of the ear. Through this bipolar clip electrode, afferent nerve fibers within the auricular branch of the vagus nerve will be stimulated. Subjects self-administer the stimulation on a daily basis for 3 months.', 'armGroupLabels': ['Active taVNS']}, {'name': 'Sham taVNS', 'type': 'DEVICE', 'otherNames': ['sham transcutaneous auricular vagus nerve stimulation'], 'description': 'A bipolar clip electrode is placed at the cymba conchae of the ear. However, active stimulation of the afferent nerve fibers within the auricular branch of the vagus nerve will not occur, because the electrode wire is electrically interrupted. Subjects self-administer the sham taVNS on a daily basis for 3 months.', 'armGroupLabels': ['Sham taVNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88001', 'city': 'Las Cruces', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Harald M Stauss, MD, PhD', 'role': 'CONTACT', 'email': 'hstauss@bcomnm.org', 'phone': '575-674-2327'}], 'facility': 'Burrell College of Osteopathic Medicine', 'geoPoint': {'lat': 32.31232, 'lon': -106.77834}}], 'centralContacts': [{'name': 'Harald M Stauss, MD, PhD', 'role': 'CONTACT', 'email': 'hstauss@burrell.edu', 'phone': '575-674-2327'}], 'overallOfficials': [{'name': 'Harald M Stauss, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burrell College of Osteopathic Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burrell College of Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}