Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-01 @ 5:11 AM
Study NCT ID:
NCT05845658
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generalised Anxiety Disorder (GAD-7) Scores', 'timeFrame': 'Up to 6 weeks', 'description': 'To evaluate the ability of the Modius Stress device, relative to the control group, in the management of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Up to 6 weeks', 'description': 'To evaluate the safety of the VeNS device relative to control group, in terms of the occurrence of adverse events.'}, {'measure': 'Quality of life using SF-36 scores', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Insomnia Severity Index (ISI) score', 'timeFrame': 'Up to 6 weeks', 'description': 'To evaluate the effect of the VeNS 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': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'The present study will be conducted at the Department of Physiology in collaboration with the Department of Psychiatry of R.D. Gardi Medical College, Ujjain, Madhya Pradesh.\n\nThis double-blind randomized controlled trial will remotely enroll 60 subjects. Each participant will complete 20 stimulation sessions at a rate of 3-5 sessions per week. Each session will be 30 minutes on the day of usage. The study will be randomized with a 1:1 active; or sham control allocation. Endpoint analysis will be performed upon completion of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)\n* Males or females 18-80 years of age inclusive on starting the study\n* Can speak/read English\n* Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis\n* Not using, and have never used, prescription, or the counter, anxiety medications\n* Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes\n\nExclusion Criteria:\n\n* History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.\n* Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent the Modius Stress device from working)\n* Medication for anxiety\n* Use of beta-blockers within 1 month of starting the study\n* Use of antidepressants or unstable dose within 3 months of starting study\n* Use of any other medical condition or medication use that in the opinion of the PI is likely to make the participant resistant to VeNS.\n* A score higher than 14 on the Insomnia Severity Index (ISI)\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* Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.).\n* Pregnancy or breast-feeding or intends to become pregnant (a pregnancy kit can be mailed if any uncertainty)\n* History of epilepsy\n* History of active migraines with aura\n* History of head injury requiring intensive care or neurosurgery\n* History of diagnosed cognitive impairment such as Alzheimer's disease/dementia\n* History of bipolar, psychotic or substance use disorders\n* Diagnosis of a current psychotic disorder\n* Regular use (more than twice a month) of antihistamine medication within the last 6 months.\n* History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)\n* A diagnosis of myelofibrosis or myelodysplastic syndrome.\n* Previous use of any VeNS device\n* Participation in other clinical trials\n* History of vestibular dysfunction or another inner ear disease"}, 'identificationModule': {'nctId': 'NCT05845658', 'briefTitle': 'Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety: A Randomized Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurovalens Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety', 'orgStudyIdInfo': {'id': 'ICNAS001'}}, '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: Active VeNS']}, {'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 VeNS']}], 'interventions': [{'name': 'Active VeNS', 'type': 'DEVICE', 'description': 'The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes 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.', 'armGroupLabels': ['Active VeNS']}, {'name': 'Sham VeNS', 'type': 'DEVICE', 'description': 'The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes 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.', 'armGroupLabels': ['Sham VeNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '456001', 'city': 'Ujjain', 'state': 'Madhya Pradesh', 'country': 'India', 'facility': 'Department of Psychiatry of R.D. Gardi Medical College', 'geoPoint': {'lat': 23.18239, 'lon': 75.77643}}], 'overallOfficials': [{'name': 'Sai Sailesh Kumar Goothy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'R.D. Gardi Medical College, Ujjain, Madhya Pradesh.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurovalens Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'R D Gardi Medical College, Ujjain', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}