- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907967
Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety
January 12, 2024 updated by: Neurovalens Ltd.
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
Anxiety is known to be one of the most common health concerns in in the general population, and the most common mental health issue, and has been associated with several health consequences.
Medications are known to be effective, and currently serve as the primary treatment for anxiety but comes with a risk of adverse effects.
Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but presents its own limitations such as the time, cost, and training required.
The relationship between vestibular stimulation and anxiety continues to be explored, however its usefulness in the treatment of anxiety is still unknown.
Vestibular stimulation itself has been shown to be safe across multiple populations.
If vestibular stimulation is shown to be effective in the treatment of anxiety, it could serve as a safer alternative to medications.
It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population.
It also could present an alternative intervention for patients who are non-responsive or refuse medication.
Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with anxiety.
Study Overview
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Coleraine, United Kingdom
- Ulster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed informed consent
- Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent.
- Report clinically significant symptoms of anxiety, defined as a score of 10 or greater on the Generalized Anxiety Disorder Scale, 7th edition (GAD-7)
- Ability and willingness to complete all study visits and procedures
- Agreement to engage with using the device on a daily basis
- Agreement to engage with trial mentors
- Agreement not to use prescription, or over the counter, anxiety medications for the duration of the trial
- Access to Wi-Fi
- Access to Apple smart phone (If not an Apple iPod will be supplied)
Exclusion Criteria:
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
- Use of beta-blockers within 1 month of starting the study
- Use of antidepressants or unstable dose within 3 months of starting study
- Medication for anxiety (unless regime stable for last 3 months).
- 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).
- Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- History of epilepsy
- History of active migraines with aura
- History of head injury requiring intensive care or neurosurgery
- History of cognitive impairment
- History of of bipolar, psychotic or substance use disorders
- Regular use (more than twice a month) of antihistamine medication within the last 6 months.
- History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- A diagnosis of myelofibrosis or a myelodysplastic syndrome.
- Previous use of Modius device
- Participation in other clinical trials sponsored by Neurovalens
- Participation in any other anxiety studies
- Have a member of the same household who is currently participating in this study.
- Not fluent in English language
- History of vestibular dysfunction or other inner ear disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active VeNS
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.
|
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.
|
Sham Comparator: Sham VeNS
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalised Anxiety Disorder (GAD-7) Scores
Time Frame: 4 weeks
|
To evaluate the effect of the VeNS device, relative to control group on participants with anxiety (range 0-21) with higher score indicating more severe anxiety.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life using SF-36 scores
Time Frame: 4 weeks
|
To evaluate the effect of the VeNS device, relative to control group, on quality of life.
SF-36 is a 36-item short form survey (range 0-100) with higher scores indicating a better quality of life.
|
4 weeks
|
Insomnia Severity Index (ISI) score
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Number of adverse events
Time Frame: 4 weeks
|
To evaluate the safety of the VeNS device relative to control group, in terms of the occurrence of adverse events.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Sittlington, PhD, Ulster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 18, 2022
Primary Completion (Actual)
April 20, 2023
Study Completion (Actual)
April 20, 2023
Study Registration Dates
First Submitted
June 8, 2023
First Submitted That Met QC Criteria
June 8, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Estimated)
January 15, 2024
Last Update Submitted That Met QC Criteria
January 12, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UUS002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on VeNS
-
Neurovalens Ltd.R D Gardi Medical College, UjjainCompleted
-
Neurovalens Ltd.R D Gardi Medical College, UjjainCompletedParkinson DiseaseIndia
-
Neurovalens Ltd.Clinical Trial MentorsCompleted
-
Neurovalens Ltd.The Hong Kong Polytechnic University; University of UlsterCompletedInsomnia | Sleep DisturbanceHong Kong, United Kingdom
-
Neurovalens Ltd.Compliance Solutions Ltd.; RD Gardi Medical CollegeCompletedInsomnia | Sleep | Sleep Disorders, Circadian RhythmIndia