Operational Performance Effects and Neurophysiology in Partial Gravity

NCT06736652 | Completed

• 1 other identifier: 2022P003142
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: Characterize and quantify changes in operationally-relevant sensorimotor and vestibular performance as a function of gravitational load. Aim 2: Characterize and quantify changes in physiology-particularly in brain function and autonomic activation during behavioral performance-as a function of gravitational load. Aim 3: Develop a model to predict behavioral performance and neurophysiological responses under different gravitational loads based on preflight ground testing data. (Hyp1) The investigators predict a monotonic but non-linear relationship between operational performance (grappling / postural sway) and gravitational load, with larger departures from 1g leading to more impaired performance. (Hyp2) The investigators predict a similar relationship between gravity load and physiological measures, with larger departures from 1g leading to larger changes in prefrontal and vestibular cortex, and autonomic nervous system activation. (Hyp3) Ground-based challenges to the vestibular system will induce detectable postural sway and neurophysiological responses. The amplitude of these responses and/or adaptation rates to the challenges (i.e., indicators of individual "sensitivity" to such provocations) will (3a) help predict neurophysiological responses in-flight, and (3b) help predict behavioral performance in flight.

Conditions

Physiological Stress

Keywords

partial gravity; microgravity; neurophyisology; behavioral performance

Outcome Measures

Primary Outcomes (2)

• ROBoT-r

  Operationally-relevant track-and capture behavioral measures

  10 days

• Postural stability

  Operationally-relevant standing balance measure

  10 days

Study Arms (1)

Main study arm

EXPERIMENTAL

All subjects perform the same activities (described in the protocol), but in different orders for counterbalancing purposes.

Other: Parabolic flight

Interventions

Parabolic flight OTHER

Preflight each individual was exposed to the 3 Other Interventions and monitored for changes in behavioral performance and neurophysiological responses. In-flight the same monitoring was conducted during partial-gravity (0.25, 0.5. 0.75g) and microgravity (\~0g).

Also known as: Galvanic vestibular stimulation, Vection, Head tilts

Main study arm

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy 30-55-year-olds
• Willingness and ability to participate in flights without motion sickness medications.
• Any Novespace requirements

You may not qualify if:

• Failure to meet medical criteria and provide certification of fitness for flight to NOVESPACE (i.e., NOVESPACE Parabolic Flight Medical Aptitude Certificate) completed by their medical doctor or an Authorized Medical Examiner
• Certain heart and lung conditions
• Dizziness
• Certain inner ear conditions
• Severe motor disability or impaired bone density
• Psychosis
• Mental disability prohibiting emergency evacuation.
• Epilepsy
• Certain neurological diseases
• Fear of heights/flying
• Debilitating anxiety and panic attacks
• Claustrophobia
• Women who are pregnant
• Certain gastrointestinal conditions
• Those taking certain medications. An individual's overall medical fitness for flight is assessed and certified by a medical doctor or Authorized Medical Examiner.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

NoveSpace

Mérignac, 33700, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: December 17, 2024
• Study Start: March 1, 2023
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available by the end-date of the funded project (estimated 5/31/2026) and be retained indefinitely.
• Access Criteria: Researchers will be allowed to request the data from the NLSP through their website: https://nlsp.nasa.gov/explore/page/home. NASA will be responsible for vetting requests and providing the data as requested.

Locations

FR (1)