Clinical Trials Directory

Trials / Completed

CompletedNCT03636126

Virtual Reality and tACS for Performance Enhancement

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Baylor Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The chronic stress of police work may reduce human performance through increases in anxiety, depression, pain, and insomnia. Land's End VR may teach mindful meditation that is associated with reduced anxiety, depression, pain, and insomnia. tACS may produce similar effects to Selective Serotonin Reuptake Inhibitors (SSRIs) without the side effect risks of SSRIs by stimulating neurotransmitter production and modulating the default mode network, resulting in reduced anxiety, depression, pain, and insomnia. These two technologies have not been investigated as interventions among police officers. Therefore, we propose a pilot randomized waitlist-controlled crossover trial of the feasibility and efficacy of Land's End VR and tACS among police officers.

Conditions

Interventions

TypeNameDescription
DEVICEVR + TACSTACS- A regulated class of transcranial alternating current stimulation (tACS), called Cranial Electrotherapy Stimulation (CES) by Fisher Wallace Laboratories (FWL) is FDA-Cleared to treat depression, anxiety, and insomnia (Proof of FDA clearance and 510k provided in the appendix). FWL tACS delivers weak non-invasive electrical stimulation (1-4 milliamps at 15, 500, and 15,000 Hz) to the frontal/temporal brain regions by electrodes placed above the temples. Land's End Virtual Reality Game Meta-analyses show Virtual Reality (VR) is an effective non-pharmacological method that reduces obstacles to human performance such as pain, insomnia, anxiety, sleep deprivation, and a variety of other stress responses.

Timeline

Start date
2019-01-03
Primary completion
2020-10-14
Completion
2020-10-14
First posted
2018-08-17
Last updated
2021-07-26

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03636126. Inclusion in this directory is not an endorsement.