Brain Changes in Response to Long-Duration Isolation and Confinement

NCT04532866 | Unknown

• 1 other identifier: 400118
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Isolation, Social; Virtual Reality; Spatial Navigation

Keywords

Sensory deprivation; Spaceflight; Social isolation; Spatial navigation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Biochemical parameters in response to sensory stimulation

  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

  pre-intervention, monthly during VR stimulation, monthly immediately after VR stimulation, monthly up to 1h after VR stimulation

Other Outcomes (4)

• Correlation between changes in brain structure and function and changes in cognitive performance

  pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion

• Correlation between changes in brain structure and function and changes in biochemical parameters

  pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion

• Correlation between changes in cognitive performance and changes in biochemical parameters

  pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion

Study Arms (2)

Isolation and Confinement

EXPERIMENTAL

Six crew members will spend 8 months isolated and confined in the spaceflight analog NEK in Moscow.

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.

Interventions

Isolation and Confinement BEHAVIORAL

Eight months of isolation and confinement in the spaceflight analog NEK in Moscow

Isolation and Confinement

Eligibility Criteria

• Age: 28 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• The Institute of Biomedical Problems (IBMP): collaborator
• National Aeronautics and Space Administration (NASA): collaborator
• European Space Agency: collaborator
• Max Planck Institute for Human Development: collaborator
• Simon Fraser University: collaborator
• University of California: collaborator
• University of York: collaborator

Study Sites (1)

NEK

Moscow, 123007, Russia

Location

MeSH Terms

Conditions

Social Isolation; Spatial Navigation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Spatial Behavior

Study Officials

• Alexander C Stahn, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 31, 2020
• Study Start: September 14, 2021
• Primary Completion: October 30, 2022
• Study Completion: June 30, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)