The Modius Stress Study
Research type
Research Study
Full 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
IRAS ID
305770
Contact name
Julie Sittlington
Contact email
Sponsor organisation
Neurovalens
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Anxiety is known to be one of the most common health concerns and is known to have detrimental effects on an individual’s mental and physical health. Medications are known to be effective, and currently serve in the primary treatment and management of anxiety but their use is limited due to the risk of adverse events. Cognitive Behavioural Therapy (CBT-I) 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 Modius Stress device is indicated to manage anxiety through the action of Cranial Electrotherapy Stimulation being delivered to the head in a non-invasive way that has been shown to be both safe and effective across multiple populations. Previous work has shown that Cranial Electrotherapy Stimulation is highly effective in managing individuals with Generalised Anxiety Disorder (GAD) even in individuals who had not responded to low intensity physiological treatment such as cognitive behaviour therapy or bibliotherapy (Morriss et al., 2019). The Modius Stress trial seeks to add to the literature to investigate if vestibular stimulation can be effective in the management of anxiety.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0009
Date of REC Opinion
1 Mar 2022
REC opinion
Further Information Favourable Opinion