Virtual Reality and tACS for Performance Enhancement
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|ClinicalTrials.gov Identifier: NCT03636126|
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Law Enforcement Officers||Device: VR + TACS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The total study time will be 4 weeks. Participants will be asked to use the VR and tACS for two of these four weeks. Participants will be randomly assigned to one of two groups: A) a group that uses the tACS+VR for weeks 1 & 2 or B) a group that uses the tACS+VR for weeks 3 & 4.|
|Masking:||None (Open Label)|
|Official Title:||Virtual Reality and tACS for Performance Enhancement|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||June 7, 2019|
Experimental: VR + TACS
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.
No Intervention: No Intervention for 2 Weeks
For 2 weeks of the 4 week study, each group (Group A and Group B) will continue work shifts as usual with no intervention.
- Numeric Rating Scale (NRS) [ Time Frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks. ]The Numerical Rating Scale (NRS) has been validated as a measure of pain intensity and is one of the most commonly used measures in assessing pain. The NRS asks patients to rate their pain severity on a 0 to 10 scale, with 0 being "no pain" to 10 being "so severe that you can't stand it."
- Insomnia Severity Index (ISI) [ Time Frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks. ]The Insomnia Severity Index (ISI) is a 7-item, self-report instrument that assesses the severity of insomnia. The ISI has adequate reliability and validity and is frequently used in randomized controlled trials of sleep interventions. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
- The Patient Health Questionnaire 8 (PHQ-8) [ Time Frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks. ]The PHQ-8 is a brief self-report measure of major depressive disorder. The PHQ-8 is considered to be valid measure of depression for population-based studies and clinical populations with a cut off score of equal or greater than 10 as the diagnostic for current depression. The PHQ-8 is derived from the PHQ-9 by removing the last question regarding suicide assessment.
- Primary Care Posttraumatic Stress Disorder Screen (PC-PTSD) [ Time Frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks. ]The PC-PTSD is a 4-item"yes" or "no" screen designed for use in medical settings and is the current screening instrument used in the VA system to screen for PTSD. This is considered a psychometrically sound screen for determining the presence and absence of PTSD in the VA setting and has also been used in the civilian primary care population. With a cut-off score of 3, the PC-PTSD has shown 85% diagnostic efficiency, 78% sensitivity, and 87% specificity.
- Generalized Anxiety Disorder (GAD7) [ Time Frame: Change in score Assessed at Baseline, 2 weeks and 4 weeks. ]The GAD7 is a 7-item questionnaire that measures severity of anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively
- Demographics Questionnaire [ Time Frame: Assessed at Baseline ]Participants will be asked to provide standard demographic information (i.e., age, gender, race/ethnicity, level of education, etc.). Participants will also be asked about hearing and visual impairment as well as any history of motion sickness.
- Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) [ Time Frame: Assessed at Baseline, 2 weeks and 4 weeks. ]Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can identify problem alcohol use. The AUDIT-C is scored o a scale of 0-12, each question has 5 answer choices with "a" being 0 points and "e" being 4 points.
- Attitudes Toward the Experience Survey [ Time Frame: Assessed at 4 weeks ]The Attitudes Toward the Experience Survey is an 8-item NRS that will be used to measure the participant's attitude toward the VR experience. Participants rate the degree to which they agree with the statements on a 1-10 scale, with 0 being "strongly disagree" and 10 being "strongly agree."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636126
|Contact: Katherine R Martin, MS||214-865-2416||Riley.Martin@BSWHealth.org|