Brain Changes in Response to Long-Duration Isolation and Confinement

Virtual Reality Clinical Trial

— BRAIVE  

Official title:

Brain Changes and Spatial Navigation After Long-Duration Isolation and Confinement and the Significance of Virtual Earth Gazing to Augment Sensory Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04532866
• Other study ID #: 400118
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study investigates the neurobehavioural risks associated with future exploratory space missions and their mitigation as part of the isolation and confinement program "SIRIUS" (Scientific International Research In Unique terrestrial Station). The overarching objective of the study is two-fold. The first objective is to investigate the time course and magnitude of eight months of isolation and confinement in the spaceflight analog facility "NEK" at the Institute of Biomedical Problems (IBMP) in Moscow on brain changes, cognitive performance, and biochemical adaptations, and compare these data to a sex- and age-matched control group. To achieve this aim, multi-modal magnetic resonance imaging (MRI) data before and after the intervention to assess structural and functional brain changes before, and after the experiment will be collected. Furthermore, cognitive performance using a series of computer-based tests will be determined and blood and saliva samples to identify biochemical changes associated with brain plasticity and learning before, during, and after the experiment will be collected. Second, to address the need for sensory stimulation countermeasures during prolonged isolation and confinement, the feasibility of a highly immersive and interactive virtual environment (VE) to enhance positive affect and mental well-being will be assessed. To achieve this aim, the acute physiological and behavioral effects associated with the proposed sensory augmentation measure will be quantified (Does VE elicit immediate physiological and/or behavioral changes during long-duration isolation and confinement?). It will be verified whether there is an adaptation to the experience with repeated exposure bouts (Can VE elicit similar physiological and or behavioral responses after the VE exposure has been administered recurrently?). The administration rate is optimized relative to crew burden/compliance and scientific return (one administration once a month). This will also ensure that the approach will not have any chronic effects interfering with the primary outcomes of the first objective or any countermeasures foreseen by IBMP. These data will provide essential insights about the efficacy of a new, highly immersive, and target specific VR-based sensory stimulation augmentation to mitigate some of the risks associated with sensory monotony and visual disconnection from Earth during exploration-type missions. The two objectives will deliver a highly unique and comprehensive set of integrated neuroimaging and neurocognitive tools for the evaluation and ultimately prevention of adverse effects on brain plasticity and behavior.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Isolation, Social
• Spatial Navigation
• Virtual Reality

Intervention

Behavioral:
• Isolation and Confinement
Eight months of isolation and confinement in the spaceflight analog NEK in Moscow

Locations

Country	Name	City	State
Russian Federation	NEK	Moscow

Sponsors (8)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

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