electrical vestibular nerve stimulation (vens) as a treatment for ptsd

Conditions: Post Traumatic Stress Disorder

Summary: trial title: a randomized, double blind sham controlled clinical trial to evaluate the efficacy of electrical vestibular nerve stimulation (vens), compared to a sham control for treatment of ptsd the aim of this study: to better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (vens) as a method of treating ptsd, as compared to a sham control. 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 400 participants. the study will last 12 weeks in total for each subject.


Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosed ptsd by a medical practitioner * post-traumatic checklist (pcl-5) score or 31 or above * eligibility confirmed via the clinician-administered ptsd scale for dsm-5 (caps-5) * male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent * ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires * ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial * agreement not to start any new ptsd, mental health, or insomnia medications for the duration of the trial and/or to inform the study team if intending on starting any new ptsd, mental health, or insomnia medications * agreement not to change any ptsd specific treatments for the duration of the trial e.g cognitive processing therapy * agreement not to undergo any significant lifestyle changes that may affect sleep (e.g. excessive exercise, sleep interventions etc.) for the duration of the trial * agreement not to use sleep trackers (e.g. fitbit) for the duration of the trial * agreement not to travel across different time zones for the duration of the trial * access to wi-fi (for app to be able to upload usage data) * access to computer, laptop, ipad or tablet (to conduct remote study visits and complete study questionnaires remotely) * screening review by ptsd physician (study pi) * willingness to download and use a video platform (e.g zoom) to conduct remote study visits * willingness to engage weekly with your clinical trial mentor (ctm) exclusion criteria: * history of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears * history of severe tinnitus or vertigo * history or presence of malignancy within the last year * use of beta-blockers within 1 month of starting the study * history of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or hiv) * use of antihistamines * 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) * taking h2-receptor antagonist medication * 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 childbearing potential and not using an adequate contraceptive method * diagnosis of epilepsy * diagnosis of active migraines * previous use of modius device * participation in other research studies sponsored by neurovalens * participation in any other ptsd studies * not fluent in english language * have a member of the same household who is currently participating in this study * failure to agree to use of device daily during study participation * any other medical condition, or medication use, that in the opinion of the pi is likely to make the subject refractory to vens.