Isolation, SocialBRAIVENCT04532866
Brain Changes in Response to Long-Duration Isolation and Confinement
A study testing Isolation and Confinement in people with Isolation, Social and Virtual Reality, run by Charite University, Berlin, Germany at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 28 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Isolation, Social, Virtual Reality, Spatial Navigation
- What is being tested?
- Isolation and Confinement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 14 Sep 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 42Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Changes and Spatial Navigation After Long-Duration Isolation and Confinement and the Significance of Virtual Earth Gazing to Augment Sensory Stimulation
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.
Read the detailed 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.
- Conditions
- Isolation, Social, Virtual Reality, Spatial Navigation
- Being tested
- Isolation and Confinement
- Keywords
- Sensory deprivation, Spaceflight, Social isolation, Spatial navigation
- Medical subject headings
- Social Isolation, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation and ConfinementBehavioural
Eight months of isolation and confinement in the spaceflight analog NEK in Moscow
| Study group | Role | What they receive |
|---|---|---|
| Isolation and Confinement | Experimental | Six crew members will spend 8 months isolated and confined in the spaceflight analog NEK in Moscow. Receives: Behavioral: Isolation and Confinement |
| Control Group | No intervention | Up to ten participants matched for age, gender, and educational background undergo the same test protocol as the experimental group at identical points in time but without being isolated and confined in the NEK facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain structure
Change in gray matter (whole brain and hippocampus) using magnetic resonance imaging (MRI).
Measured: pre-intervention, immediately after the intervention, up to 30 days after study completion
Change in brain function
Change in BOLD signal using functional magnetic resonance imaging (fMRI).
Measured: pre-intervention, immediately after the intervention, up to 30 days after study completion
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.
Measured: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
Change in biochemical parameters
Percent change in BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain using serum, plasma and EDTA samples.
Measured: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
Change in stress response
Percent change in salivary cortisol using a cotton swab system.
Measured: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
Secondary outcomes (2)
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).
Measured: Baseline, monthly during the VR intervention, immediately after each VR intervention, and up to 1h after the VR intervention
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).
Measured: pre-intervention, monthly during VR stimulation, monthly immediately after VR stimulation, monthly up to 1h after VR stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start14 Sep 2021
- Primary completion30 Oct 2022
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolation, SocialStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Biomedical Problems (IBMP), National Aeronautics and Space Administration (NASA), European Space Agency, Max Planck Institute for Human Development, Simon Fraser University, University of California, University of York
- Responsible party
- Principal investigator, Alexander C. Stahn, Charite University, Berlin, Germany
- Investigators
- Alexander C Stahn, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532866
- Sponsor's protocol ID
- 400118
- Acronym
- BRAIVE
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Changes and Spatial Navigation After Long-Duration Isolation and Confinement and the Significance of Virtual Earth Gazing to Augment Sensory Stimulation
- ClinicalTrials.gov ID
- NCT04532866
- Acronym / sponsor ID
- BRAIVE / 400118
- Conditions
- Isolation, Social, Virtual Reality, Spatial Navigation
- Keywords
- Sensory deprivation, Spaceflight, Social isolation, Spatial navigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- The Institute of Biomedical Problems (IBMP), National Aeronautics and Space Administration (NASA), European Space Agency, Max Planck Institute for Human Development, Simon Fraser University, University of California, University of York
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolation and Confinement | Experimental | Behavioral: Isolation and ConfinementSix crew members will spend 8 months isolated and confined in the spaceflight analog NEK in Moscow. |
| Control Group | No intervention | –Up to ten participants matched for age, gender, and educational background undergo the same test protocol as the experimental group at identical points in time but without being isolated and confined in the NEK facility. |
Who may qualify
- Ages
- 28 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (42 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolation and ConfinementEight months of isolation and confinement in the spaceflight analog NEK in Moscow | Behavioural | Isolation and Confinement |
Primary outcome
Change in brain structure
Time frame: pre-intervention, immediately after the intervention, up to 30 days after study completion
Change in gray matter (whole brain and hippocampus) using magnetic resonance imaging (MRI).
Change in brain function
Time frame: pre-intervention, immediately after the intervention, up to 30 days after study completion
Change in BOLD signal using functional magnetic resonance imaging (fMRI).
Change in cognitive performance
Time frame: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
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.
Change in biochemical parameters
Time frame: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
Percent change in BDNF, IGF-1, VEGF, oxytocin, and neurofilament light chain using serum, plasma and EDTA samples.
Change in stress response
Time frame: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
Percent change in salivary cortisol using a cotton swab system.
2 secondary outcomes
Biochemical parameters in response to sensory stimulation
Time frame: Baseline, monthly during the VR intervention, immediately after each VR intervention, and up to 1h after the VR intervention
Markers of mood and mental well-being in response to sensory stimulation
Time frame: pre-intervention, monthly during VR stimulation, monthly immediately after VR stimulation, monthly up to 1h after VR stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander C Stahn, PhD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolation and Confinement in people with Isolation, Social and Virtual Reality, run by Charite University, Berlin, Germany at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain structure (time frame: pre-intervention, immediately after the intervention, up to 30 days after study completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.