General Anxiety DisorderNCT06956105
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Anxiety in Adolescents
A study testing Modius Calm in people with General Anxiety Disorder, run by Neurovalens Ltd. at 1 site in India.
Trial summary
Trial 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 in Adolescents - The Modius Calm Adolescent Study The aim of this study: This investigation aims to evaluate the effects… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- General Anxiety Disorder
- What is being tested?
- Modius Calm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 8 Sep 2025to 13 Jun 2026
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed Informed Consent
- Signed Assent Form
- Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
- GAD-7 score of >/=10 at screening
- Can speak and read English
- Ability and willingness to travel to the clinic to complete all study visits, stimulation sessions and procedures
- Ability and willingness to adhere to 30 minutes usage of the device 5 days per week for the duration of the trial at clinic
- Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact anxiety e.g. dietary or exercise changes
Who cannot join
- GAD-7 score of < 10 at screening
- Medication for anxiety
- Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
- Risk of persistent self-harm or suicide
- Diagnosis or history of bipolar disorder
- History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
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- Diagnosis of substance use disorder or dependence
- Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
- History of diagnosed cognitive impairment / disorder such as delirium or dementia
- Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
- History of stroke or head injury requiring intensive care or neurosurgery
- Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
- History of epilepsy
- History of severe tinnitus or vertigo
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- History of vestibular dysfunction or another inner ear disease
- Regular use (more than twice a month) of antihistamine medication within the last 6 months
- Diagnosis of active migraines
- Previous use of Modius device or any VeNS device
- Participation in other clinical trials sponsored by Neurovalens
- Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
- Failure to use device daily during trial participation (no more than 7 consecutive days usage drop without reasonable explanation)
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 in Adolescents - The Modius Calm Adolescent Study
Trial 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 in Adolescents - The Modius Calm Adolescent Study
The aim of this study: This investigation aims to evaluate the effects of VeNS for the treatment of Generalized Anxiety Disorder, to contribute to the field of knowledge about the neurological mechanisms to determine whether the relatively inexpensive, and non-invasive technique of VeNS can reduce the severity of GAD symptoms in adolescents.
Read more
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study
Intervention Model: Parallel Assignment in 1:1 active to control allocation
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.
Read the detailed description
This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the BGS MCH Hospital. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the clinic. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:
- Baseline: Study Visit 1 (0-week timepoint for enrolment)
- Study Visit 2 (2-week timepoint)
- End of Study (4-week timepoint)
- Post-intervention follow-up at 2 weeks (6-week timepoint)
- Post-intervention follow-up at 6 weeks (10-week timepoint)
- Post-intervention follow-up at 8 weeks (12-week timepoint)
- Conditions
- General Anxiety Disorder
- Being tested
- Modius Calm, Sham device
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modius CalmDevice
The Modius Calm device is a transdermal neurostimulation product. It consists of a battery-powered headset designed to deliver low-level energy in the form of a neurostimulation waveform that modulates the activity of the vestibular cranial nerve. The active Modius Calm device utilizes a technology called electrical vestibular nerve stimulation (VeNS). In the envisaged configuration the device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current (a maximum of 1.5mA) to the skin behind the ears over the mastoid processes.
Sham deviceDevice
The sham device is identical in appearance. The Modius Calm sham device follows this pattern by applying 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.
| Study group | Role | What they receive |
|---|---|---|
| Active VeNS device | Experimental | 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: Modius Calm |
| Sham device | Sham comparator | The sham device looks identical 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: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in GAD-7 score from baseline to 4 weeks
Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. GAD-7 has seven items, which measure severity of various signs of GAD according to reported response categories with assigned points. The GAD-7 items include: 1) nervousness; 2) inability to stop worrying; 3) excessive worry; 4) restlessness; 5) difficulty in relaxing; 6) easy irritation; and 7 fear of something awful happening. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was originally validated in a primary care sample and a cut-off score of 10 had a sensitivity value of 0.89 and a specificity value of 0.82 for identifying GAD.
Measured: The GAD-7 shall be completed at baseline, 4 weeks (end of intervention) and 2 weeks, 6 weeks and 8 weeks post intervention .
Secondary outcomes (3)
Change in the Insomnia Severity Index (ISI) score from baseline to 4 weeks
The Insomnia Severity Index (ISI) is a validated short, self-report screening assessment tool designed to evaluate insomnia by measuring an individual's perception of both day and night symptoms of insomnia. The Index consists of seven items which are each assessed in terms of perceived difficulty: falling sleep, staying asleep, and time of awakening, satisfaction with current sleep pattern, interference with daily functioning, noticeability by others of impact of lack of sleep, and degree of perceived distress or concern caused by the sleep problem.
Measured: The ISI shall be completed at baseline and repeated at both 2 (mid-point) and 4 weeks (end of study).
Change in the Mental Health-related Quality of Life (SF-36) mental component (MC) score from baseline to 4 weeks
The SF-36 is a widely used, self-reported health-related quality of life (HRQoL) questionnaire designed to measure functional health and well-being from the patient's perspective. It assesses eight key domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each domain is scored individually and can be combined into two overall summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). In this study, the PCS and MCS scores will be the primary focus, allowing to evaluate changes in both physical and mental aspects of health over time. The questionnaire has been validated in diverse populations, including adolescents, and is commonly used in clinical trials and health outcome research.
Measured: The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).
Change in the Physical Health-related Quality of Life (SF-36) physical component (MC) score from baseline to 4 weeks.
The SF-36 is a widely used, self-reported health-related quality of life (HRQoL) questionnaire designed to measure functional health and well-being from the patient's perspective. It assesses eight key domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each domain is scored individually and can be combined into two overall summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). In this study, the PCS and MCS scores will be the primary focus, allowing to evaluate changes in both physical and mental aspects of health over time. The questionnaire has been validated in diverse populations, including adolescents, and is commonly used in clinical trials and health outcome research.
Measured: The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start8 Sep 2025
- Primary completion13 Jun 2026
- Study completion13 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anxiety DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sai Sailesh Kumar Goothy, Principal investigator, BGS MCH Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956105
- Sponsor's protocol ID
- NV-MC-2025-001
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. 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 in Adolescents - The Modius Calm Adolescent Study
- ClinicalTrials.gov ID
- NCT06956105
- Acronym / sponsor ID
- NV-MC-2025-001
- Conditions
- General Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 13 Jun 2026 (actual)
- Study completion
- 13 Jun 2026 (actual)
- First posted
- 2 May 2025 (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.
Trial 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 in Adolescents - The Modius Calm Adolescent Study
The aim of this study: This investigation aims to evaluate the effects of VeNS for the treatment of Generalized Anxiety Disorder, to contribute to the field of knowledge about the neurological mechanisms to determine whether the relatively inexpensive, and non-invasive technique of VeNS can reduce the severity of GAD symptoms in adolescents.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study
Intervention Model: Parallel Assignment in 1:1 active to control allocation
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.
Detailed description
This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the BGS MCH Hospital. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the clinic. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:
- Baseline: Study Visit 1 (0-week timepoint for enrolment)
- Study Visit 2 (2-week timepoint)
- End of Study (4-week timepoint)
- Post-intervention follow-up at 2 weeks (6-week timepoint)
- Post-intervention follow-up at 6 weeks (10-week timepoint)
- Post-intervention follow-up at 8 weeks (12-week timepoint)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VeNS device | Experimental | Device: Modius CalmThe 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 device | Sham comparator | Device: Sham deviceThe sham device looks identical 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
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Signed Informed Consent
- Signed Assent Form
- Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
- GAD-7 score of >/=10 at screening
- Can speak and read English
Key exclusion criteria (23 listed)
- GAD-7 score of < 10 at screening
- Medication for anxiety
- Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
- Risk of persistent self-harm or suicide
- Diagnosis or history of bipolar disorder
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 |
|---|---|---|
| Modius CalmThe Modius Calm device is a transdermal neurostimulation product. It consists of a battery-powered headset designed to deliver low-level energy in the form of a neurostimulation waveform that modulates the activity of the vestibular cranial nerve. The active Modius Calm device utilizes a technology called electrical vestibular nerve stimulation (VeNS). In the envisaged configuration the device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current (a maximum of 1.5mA) to the skin behind the ears over the mastoid processes. | Device | Active VeNS device |
| Sham deviceThe sham device is identical in appearance. The Modius Calm sham device follows this pattern by applying 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. | Device | Sham device |
Primary outcome
The change in GAD-7 score from baseline to 4 weeks
Time frame: The GAD-7 shall be completed at baseline, 4 weeks (end of intervention) and 2 weeks, 6 weeks and 8 weeks post intervention .
Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. GAD-7 has seven items, which measure severity of various signs of GAD according to reported response categories with assigned points. The GAD-7 items include: 1) nervousness; 2) inability to stop worrying; 3) excessive worry; 4) restlessness; 5) difficulty in relaxing; 6) easy irritation; and 7 fear of something awful happening. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was originally validated in a primary care sample and a cut-off score of 10 had a sensitivity value of 0.89 and a specificity value of 0.82 for identifying GAD.
3 secondary outcomes
Change in the Insomnia Severity Index (ISI) score from baseline to 4 weeks
Time frame: The ISI shall be completed at baseline and repeated at both 2 (mid-point) and 4 weeks (end of study).
Change in the Mental Health-related Quality of Life (SF-36) mental component (MC) score from baseline to 4 weeks
Time frame: The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).
Change in the Physical Health-related Quality of Life (SF-36) physical component (MC) score from baseline to 4 weeks.
Time frame: The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (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 1 Jul 2026.
- 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.
Sai Sailesh Kumar Goothy principal investigator
BGS MCH Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modius Calm in people with General Anxiety Disorder, run by Neurovalens Ltd. at 1 site in India.
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 8 inclusion and 23 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 1 Jul 2026. 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 India. 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?
The change in GAD-7 score from baseline to 4 weeks (time frame: The GAD-7 shall be completed at baseline, 4 weeks (end of intervention) and 2 weeks, 6 weeks and 8 weeks post intervention .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.