Virtual Reality and tACS for Performance Enhancement

NCT03636126 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-07-26

No results posted yet for this study

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

  • Law Enforcement Officers

Interventions

DEVICE

VR + TACS

TACS- 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.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2020-10-14
Completion
2020-10-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636126 on ClinicalTrials.gov