AnxietyNCT05907967
Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety
A study testing VeNS in people with Anxiety, run by Neurovalens Ltd. at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety
- What is being tested?
- VeNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety
- Being tested
- VeNS
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeNSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active VeNS | Active comparator | 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. Receives: Device: VeNS |
| Sham VeNS | Sham comparator | 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. Receives: Device: VeNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalised Anxiety Disorder (GAD-7) Scores
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.
Measured: 4 weeks
Secondary outcomes (3)
Number of adverse events
To evaluate the safety of the VeNS device relative to control group, in terms of the occurrence of adverse events.
Measured: 4 weeks
Quality of life using SF-36 scores
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.
Measured: 4 weeks
Insomnia Severity Index (ISI) score
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start18 Jul 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ulster University
- Responsible party
- Sponsor
- Investigators
- Julie Sittlington, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907967
- Sponsor's protocol ID
- UUS002
- Status last verified
- Jan 2024
- First submitted
- 8 Jun 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Curry G, Zhang SD, McAnena L, Price RK, Sittlington JJ. Repeated Electrical Vestibular Nerve Stimulation Reduces Anxiety in People With Moderate-to-Severe Anxiety: A Randomized, Sham-Controlled Trial: The Modius Anxiety Study. Neuromodulation. 2026 Jun;29(4):626-636. doi: 10.1016/j.neurom.2025.11.008. Epub 2026 Feb 5.
PubMed 41642155
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05907967
- Acronym / sponsor ID
- UUS002
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Ulster University
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VeNS | Active comparator | Device: VeNSThe 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. |
| Sham VeNS | Sham comparator | Device: VeNSThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeNSThe 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. | Device | Active VeNS, Sham VeNS |
Primary outcome
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.
3 secondary outcomes
Number of adverse events
Time frame: 4 weeks
Quality of life using SF-36 scores
Time frame: 4 weeks
Insomnia Severity Index (ISI) score
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 41642155Curry G, Zhang SD, McAnena L, Price RK, Sittlington JJ. Repeated Electrical Vestibular Nerve Stimulation Reduces Anxiety in People With Moderate-to-Severe Anxiety: A Randomized, Sham-Controlled Trial: The Modius Anxiety Study. Neuromodulation. 2026 Jun;29(4):626-636. doi: 10.1016/j.neurom.2025.11.008. Epub 2026 Feb 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Sittlington, PhD principal investigator
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeNS in people with Anxiety, run by Neurovalens Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalised Anxiety Disorder (GAD-7) Scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.