Virtual Reality Clinical Trial
— BRAIVEOfficial title:
Brain Changes and Spatial Navigation After Long-Duration Isolation and Confinement and the Significance of Virtual Earth Gazing to Augment Sensory Stimulation
Verified date | August 2023 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates the time course and magnitude of eight months of isolation and confinement in a spaceflight analog facility on brain changes and cognitive performance. The study also assesses the feasibility of an immersive and interactive virtual environment (VE) to enhance positive affect and mental well-being during prolonged isolation and confinement.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | June 30, 2024 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 28 Years to 55 Years |
Eligibility | Inclusion Criteria: - Candidates who are professionals in the aerospace industry or related fields are eligible at a lower age limit of 28 - Height not to exceed 180 cm. - Willing to be confined and isolated for up to 8 months. - English and Russian verbal and written proficiency not lower than intermediate - Absence of chronic disease or psychological deviations Exclusion Criteria: - Everybody who does not meet listed above requirements - Past mental, cardiovascular, musculoskeletal and/or neurovestibular disorders or diseases - Pronounced orthostatic intolerance or vestibular balance disorders (kinetosis) - Abuses of drugs, medication or alcohol - Claustrophobia - Malnutrition up to 6 months before the start of the study - Intake of anabolic steroids up to 6 months before study initiation - Metal implants or other osteosynthesis materials - Bisphosphonate therapy - Taking medication that could influence the results of the examination. - Taking hormonal contraceptives in the last 6 months before the start of the study - Menstrual disorders - Delivery up to 6 months before the start of studies - clinically manifest abnormalities in the resting ECG that preclude participation in the study - Hypertension (> 130/85 mmHg) - Increased risk of thrombosis - Increased risk of stroke - Infection with HIV or HBV - HIV, hepatitis A, B, or tuberculosis infection - clinically manifest changes in the differential blood count - Clinically manifest changes according to the Comprehensive Metabolic Panel (CMP) (blood urea, uric acid, creatinine, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline Phosphatase (ALP), L-Lactate dehydrogenase (LDH), Glutamyltransferase (GGT), sodium, potassium, chloride, phosphorus, calcium, magnesium, CO2, total protein, albumin, globulin, fasting glucose (< 100mg/dL) - clinically manifest iron deficiency: < 10 mg/L or < 20 mg/L for women and men respectively - clinically manifest lipid metabolism disorders - clinically manifest vitamin D deficiency - clinical manifest increase of C-reactive protein - Tuberculosis infection - Gastroesophageal reflux - Ulcers - Kidney disease and/or kidney stones - Thyroid dysfunction - Tinnitus - Sensorineural hearing loss from 30 dB - Pacemaker or internal defibrillator - metallic implants (e.g. orthopaedic plates after bone fractures, joint replacement, surgical clips or staples, artificial heart valves, vein filters) - metallic splinters (e.g. after an accident or because of war injury) - non-removable braces - Tattoos with unknown color composition - Permanent Make-up - Cochlear implant (implanted hearing aid) - Medication pump - Acupuncture needles - Any other condition which, in the opinion of the investigator, renders the subject unfit for inclusion in the study |
Country | Name | City | State |
---|---|---|---|
Russian Federation | NEK | Moscow |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | European Space Agency, Max Planck Institute for Human Development, National Aeronautics and Space Administration (NASA), Simon Fraser University, The Institute of Biomedical Problems (IBMP), University of California, University of York |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Correlation between changes in brain structure and function and changes in cognitive performance | Correlation between changes in brain structure and function and changes in reaction time, accuracy, spatial updating, path integration, visuo-spatial memory and learning, spatial orientation ability, and navigation strategy preferences. | pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion | |
Other | Correlation between changes in brain structure and function and changes in biochemical parameters | Correlation between changes in brain structure and function and changes in BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain. | pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion | |
Other | Correlation between changes in cognitive performance and changes in biochemical parameters | Correlation between changes in reaction time, accuracy, spatial updating, path integration, visuo-spatial memory and learning, spatial orientation ability, and navigation strategy preferences and changes in BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain. | pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion | |
Other | Correlation between changes in biochemical parameters and markers of mood and mental well-being in response to sensory stimulation | Correlation between changes in percent of salivary cortisol and BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain and markers of mood and mental well-being assessed by Visual Analog Scales in response to sensory stimulation using virtual reality (VR). | pre-intervention, monthly during VR stimulation, monthly immediately after VR stimulation, monthly up to 1h after VR stimulation | |
Primary | Change in brain structure | Change in gray matter (whole brain and hippocampus) using magnetic resonance imaging (MRI). | pre-intervention, immediately after the intervention, up to 30 days after study completion | |
Primary | Change in brain function | Change in BOLD signal using functional magnetic resonance imaging (fMRI). | pre-intervention, immediately after the intervention, up to 30 days after study completion | |
Primary | Change in cognitive performance | Change in reaction time, accuracy, spatial updating, path integration, visuo-spatial memory and learning, spatial orientation ability, and navigation strategy preferences using a cognitive test battery. | pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion | |
Primary | Change in biochemical parameters | Percent change in BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain using serum, plasma and EDTA samples. | pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion | |
Primary | Change in stress response | Percent change in salivary cortisol using a cotton swab system. | pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion | |
Secondary | Biochemical parameters in response to sensory stimulation | Assessing whether percent of salivary cortisol and the biochemical parameters BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain change in response to a sensory stimulation using virtual reality (VR). | Baseline, monthly during the VR intervention, immediately after each VR intervention, and up to 1h after the VR intervention | |
Secondary | Markers of mood and mental well-being in response to sensory stimulation | Assessing by means of Visual Analog Scales whether subjective markers of mood and mental well-being change in response to sensory stimulation using virtual reality (VR). | pre-intervention, monthly during VR stimulation, monthly immediately after VR stimulation, monthly up to 1h after VR stimulation |
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