Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT05242367
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posttraumatic Stress Disorder Checklist PCL-5 score', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the Modius Sleep device, relative to control group, on the symptoms of PTSD, quantified by change in the PCL-5 Score.'}], 'secondaryOutcomes': [{'measure': '36-Item Short Form Survey (SF-36) score', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the Modius Spero device, relative to control group, on quality of life quantified by change in SF-36 score.'}, {'measure': 'Generalised Anxiety Disorder (GAD-7) score', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the Modius Spero device, relative to control group, on anxiety, quantified by change in the GAD-7 score. GAD-7 is a self-report rating scale assessing the severity of anxiety (range 0-21), with higher score indicating more severe anxiety.'}, {'measure': 'Insomnia Severity Index (ISI) score', 'timeFrame': '12 weeks', 'description': 'To evaluate the effect of the Modius Spero device, relative to control group, on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of PTSD\n\nThe aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating PTSD, as compared to a sham control.\n\nAllocation: Randomized to either active device or control device usage.\n\nEndpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation\n\nSample size: The aim is to recruit a total of up to 400 participants. The study will last 12 weeks in total for each subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Diagnosed PTSD by a medical practitioner\n* Post-Traumatic Checklist (PCL-5) score or 31 or above\n* Eligibility confirmed via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)\n* Male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent\n* Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires\n* Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial\n* Agreement not to start any new PTSD, mental health, or insomnia medications for the duration of the trial and/or to inform the study team if intending on starting any new PTSD, mental health, or insomnia medications\n* Agreement not to change any PTSD specific treatments for the duration of the trial e.g cognitive processing therapy\n* Agreement not to undergo any significant lifestyle changes that may affect sleep (e.g. excessive exercise, sleep interventions etc.) for the duration of the trial\n* Agreement not to use sleep trackers (e.g. Fitbit) for the duration of the trial\n* Agreement not to travel across different time zones for the duration of the trial\n* Access to Wi-Fi (for app to be able to upload usage data)\n* Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely)\n* Screening review by PTSD physician (study PI)\n* Willingness to download and use a video platform (e.g Zoom) to conduct remote study visits\n* Willingness to engage weekly with your Clinical Trial Mentor (CTM)\n\nExclusion Criteria:\n\n* History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears\n* History of severe tinnitus or vertigo\n* History or presence of malignancy within the last year\n* Use of beta-blockers within 1 month of starting the study\n* History of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or HIV)\n* Use of antihistamines\n* A history of stroke or severe head injury as defined by a head injury that required a craniotomy or endotracheal intubation (in case this damaged the neurological pathways involved in vestibular stimulation)\n* Taking H2-receptor antagonist medication\n* Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method\n* Diagnosis of epilepsy\n* Diagnosis of active migraines\n* Previous use of Modius device\n* Participation in other research studies sponsored by Neurovalens\n* Participation in any other PTSD studies\n* Not fluent in English language\n* Have a member of the same household who is currently participating in this study\n* Failure to agree to use of device daily during study participation\n* Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.'}, 'identificationModule': {'nctId': 'NCT05242367', 'briefTitle': 'Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurovalens Ltd.'}, 'officialTitle': 'A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Post- Traumatic Stress Disorder (PTSD)', 'orgStudyIdInfo': {'id': 'MS003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active VeNS', 'description': 'The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.', 'interventionNames': ['Device: Modius Spero active device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham VeNS', 'description': 'The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.', 'interventionNames': ['Device: Sham device']}], 'interventions': [{'name': 'Modius Spero active device', 'type': 'DEVICE', 'description': 'Battery powered non-invasive neurostimulation device', 'armGroupLabels': ['Active VeNS']}, {'name': 'Sham device', 'type': 'DEVICE', 'description': 'Placebo comparator sham device (no active stimulation)', 'armGroupLabels': ['Sham VeNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Peter Colvonen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurovalens Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'Clinical Trial Mentors', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}