Physiological StressOPEN-PGNCT06736652
Operational Performance Effects and Neurophysiology in Partial Gravity
A study testing Parabolic flight in people with Physiological Stress, run by Massachusetts General Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress
- What is being tested?
- Parabolic flight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 16 Jun 2023
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 30-55-year-olds
- Willingness and ability to participate in flights without motion sickness medications.
- Any Novespace requirements
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Physiological Recording Setup: Dr. Strangman's NINscan devices support 64-channel near-infrared spectroscopy (NIRS), plus multiple electrophysiological and related measurements. The NIRS pad will be positioned to span the right lateral prefrontal cortex to parietal vestibular cortex, given the typical right-lateralization of the working memory, spatial processing, and vestibular brain functions under investigation 2, 7, 22. A multi-separation probe will help remove scalp and skull hemodynamic interference in the fNIRS signal 25, 27. Accelerometers will be placed on the head and sacrum to detect motion artifacts and sway. Planned additional sensors will include EEG over prefrontal and parietal locations (e.g., International Standard locations Fz/F7/P3 14) plus two electrooculography sensors to measure eye movements, 1 ECG sensor for cardiac activity, two facial electromyography sensors, skin temperature, and electrodermal activity (EDA). Skin markers may be used to facilitate flight-day setup.
Phase 0: On-Ground (Preflight) Subject Training Preflight Training: Preflight training will focus on the following: (i) self-deployment of the NINscan system, and performance of (ii) the ROBoT-r task, and (iii) postural sway. On Day 1, subjects will participate in a ~90-min Familiarization session, followed by a 1st ~90-min Training session. On Day 2, subjects will perform the 2nd Training session. Each Training session will include a 10-min resting-state baseline period during which subjects will sit quietly with their eyes-open (to practice and to provide baseline data on e.g. functional connectivity, intracranial pulsatility, BP, EEG, and EDA), followed by performance of ROBoT-r and postural sway tasks.
NINscan: Familiarization will include instruction on the hardware, self-deployment, safe operation, and basic troubleshooting. For training sessions, participants will self-deploy the device, including attachment of all brain and physiologic sensors, and collect data while performing ROBoT-r and postural sway tasks, with instructor supervision throughout.
ROBoT Docking: Participants will perform ROBoT-r training via our published approach 5, including instruction on (i) system components, (ii) performance criteria, and (iii) basic troubleshooting. During training sessions, participants will deploy ROBoT-r and perform a full session (12 runs) while standing on a posturography platform and wearing NINscan.
Postural Sway: During familiarization, participants will learn to safely maintain upright stance on a Zibrio-Pro (Zibrio, Houston, TX) computerized posturography platform. This will involve standing upright with head erect, arms next to their body, with their feet on the platform at shoulder width. The subjects will then be familiarized with the vestibular challenges: (1) performance of ±20⁰ dynamic head pitch-tilt oscillations at 0.33 Hz paced by an audible tone 12, 13, (2) viewing the circularly-rotating visual stimulus and reporting vection sensations, and (3) the Galvanic vestibular stimulation system. The Training sessions will not involve any vestibular challenges, just practice with the balance/posturography testing.
Phase 1: On-Ground (Preflight) Baseline Data Collection Ground Baseline Data Collection (BDC): After training, participants will participate in three baseline data collection procedures, spread over 3 days to minimize interference effects. Each session will include a rest recording, postural sway, docking, and one of our three neurovestibular challenges (counterbalanced to minimize potential order effects).
BDC Rest Recording: Each participant will fill out the Motion Sickness Susceptibility Questionnaire (MSSQ) first 3. They will then self-deploy the NINscan recording device (with experimenter oversight) to wear throughout the BDC period, starting with a 10-min rest recording.
BDC Postural Sway: Participants will then perform the postural sway task (above), using NINscan while standing on the computerized posturography platform to obtain baseline sway at 1g.
BDC Docking: Next, participants will perform a set of 12 ROBoT-r runs. Brief rest periods will occur between runs. This will provide baseline data on operationally relevant task performance in 1g.
BDC Neurovestibular Challenges: For our predictive models (Aim 3), the investigators will assess participants' preflight responses to three neurovestibular challenges, each based on a distinct type of sensory input. NINscan recordings will record throughout each exposure period. Challenges will be provided on each of 3 consecutive days, in counterbalanced orders. A Likert-style motion sickness scale (0-10) will be used to assess acute symptoms 11, while the Motion Sickness Symptoms Questionnaire (MSSQ) will be administered before and after each data collection session. All vestibular challenges will be performed while standing on the Zibrio posturography plate. Postural Sway recordings will start 2 min prior to vestibular challenges, and continue until 2 min after completion of challenges, each as described below.
- Galvanic vestibular stimulation (GVS) and adaptation (electrical input) 1, 8, 9. Participants standing on the posturography platform will undergo 25s periods of GVS over the mastoid processes (interleaved with rest periods) using a pseudorandom current waveform stimulus consisting of a sum-of-sines (0.16, 0.33, 0.43, 0.61 Hz) with a peak amplitude of 5 mA. These parameters are designed to replicate the postflight sensorimotor experience of astronauts 1. Three cycles of twelve alternations will be presented every 15 minutes for a total of 45 minutes to assess adaptation.
- Roll-vection and adaptation (visual input, non-otolith) 10, 15, 23. Standing subjects will view a central fixation cross on a computer monitor. A sparse field of stars will be rotated around the central point (60 deg/s), while the stars themselves rotate in the same direction to enhance the vection effect (60 deg/s) 10. Participants press a key whenever vection (self-rotation in the opposite direction of the visual stimulus) is perceived, and release it when the perception ceases 10. Stimulus periods will be 25s long, interleaved with 25s periods of a blank screen. During the blank screens, participants will verbally report the strength of the vection perception on a 0-100 scale (0=none, 50=the same vection as perceived in an initial, pretest single exposure to a globally-rotating stimulus 10). Again, three cycles of twelve stimulus/blank exposures will be presented every 15 minutes for a total of 45 minutes to assess adaptation.
- Oscillatory head pitch (mechanical input) 12, 13. Standing participants will either hold their head erect and static (HS), or perform continuous ±20 dynamic pitch oscillations (head dynamic, HD) at 0.33 Hz paced by an audible tone transmitted through lightweight headphones. White noise supplied through headphones will mask external auditory orientation cues. Three cycles of 12 HS and HD alternations will be performed during 45 minutes to assess adaptation.
Phase 2: Flight Data Collection
Flight testing: On flight day, participants will be pre-instrumented on the ground for rapid NINscan deployment. Anti-motion sickness medication will not be allowed for these participants, as it interferes with the neurovestibular measurements the investigators are making. Participants board the Airbus A310 ZERO-G and fasten seatbelts for takeoff. After takeoff, the pilots fly the aircraft to a specific air zone where the parabolas will take place. With other members of the participant's group and the instructor, participants will then move to the area of the cabin. Participants will receive instructions from Novespace to maintain safety during the parabolic flight. Upon reaching level flight, participants will don NINscan, start NINscan recording, and initialize the ROBoT-r equipment. Each participant will stand on a computerized posturography platform and perform two tasks during the 10 parabolas at each gravitational load (and for equivalent time periods during level flight at 1g): (1) operationally-relevant ROBoT-r task for the first 7 parabolas, and (2) postural sway assessment on the last 3 parabolas. As currently scheduled, there will be two flights for each participant. The first flight will include all n=12 participants and fly 31 parabolas, the first of which is for general orientation. Groups of 4 subjects will simultaneously perform the described tasks for 10 parabolas, and then they will switch places with the next group of 4 subjects. On the second flight for each participant, the plane will fly 31 parabolas again, the first being for orientation. After that, 3 sets of 10 parabolas will be flown, each set at a different gravity level (nominally 0.25, 0.5 and 0.75g). Participants will perform tasks during all three groups of 10 parabolas, identical to the 10 parabolas at 0. An additional period of level flight will be performed where participants again perform the same tasks on the same timeline, but at 1g. Participants will be closely monitored throughout by a dedicated experimenter and/or harnessed (as required by Novespace) to ensure safety.
If a participants agrees to the photo/video clause in the informed consent, photos/videos of their participation may be conducted during the flight. These will either be taken from behind the participant, or any facial features will be blurred and prior to use in any presentation or publication form.
There will be no post-flight activities for the participants.
- Conditions
- Physiological Stress
- Being tested
- Parabolic flight
- Keywords
- partial gravity, microgravity, neurophyisology, behavioral performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
Also called Galvanic vestibular stimulation, Vection, Head tilts
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).
| Study group | Role | What they receive |
|---|---|---|
| Main study arm | Experimental | All subjects perform the same activities (described in the protocol), but in different orders for counterbalancing purposes. Receives: Other: Parabolic flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROBoT-r
Operationally-relevant track-and capture behavioral measures
Measured: 10 days
Postural stability
Operationally-relevant standing balance measure
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Mar 2023
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Responsible party
- Principal investigator, Gary E. Strangman, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736652
- Sponsor's protocol ID
- 2022P003142
- Acronym
- OPEN-PG
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD from this project will be anonymized IPD and shared. Data will be coded with a key only available to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Performance Effects and Neurophysiology in Partial Gravity
- ClinicalTrials.gov ID
- NCT06736652
- Acronym / sponsor ID
- OPEN-PG / 2022P003142
- Conditions
- Physiological Stress
- Keywords
- partial gravity, microgravity, neurophyisology, behavioral performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 17 Dec 2024 (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.
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.
Detailed description
Physiological Recording Setup: Dr. Strangman's NINscan devices support 64-channel near-infrared spectroscopy (NIRS), plus multiple electrophysiological and related measurements. The NIRS pad will be positioned to span the right lateral prefrontal cortex to parietal vestibular cortex, given the typical right-lateralization of the working memory, spatial processing, and vestibular brain functions under investigation 2, 7, 22. A multi-separation probe will help remove scalp and skull hemodynamic interference in the fNIRS signal 25, 27. Accelerometers will be placed on the head and sacrum to detect motion artifacts and sway. Planned additional sensors will include EEG over prefrontal and parietal locations (e.g., International Standard locations Fz/F7/P3 14) plus two electrooculography sensors to measure eye movements, 1 ECG sensor for cardiac activity, two facial electromyography sensors, skin temperature, and electrodermal activity (EDA). Skin markers may be used to facilitate flight-day setup.
Phase 0: On-Ground (Preflight) Subject Training Preflight Training: Preflight training will focus on the following: (i) self-deployment of the NINscan system, and performance of (ii) the ROBoT-r task, and (iii) postural sway. On Day 1, subjects will participate in a ~90-min Familiarization session, followed by a 1st ~90-min Training session. On Day 2, subjects will perform the 2nd Training session. Each Training session will include a 10-min resting-state baseline period during which subjects will sit quietly with their eyes-open (to practice and to provide baseline data on e.g. functional connectivity, intracranial pulsatility, BP, EEG, and EDA), followed by performance of ROBoT-r and postural sway tasks.
NINscan: Familiarization will include instruction on the hardware, self-deployment, safe operation, and basic troubleshooting. For training sessions, participants will self-deploy the device, including attachment of all brain and physiologic sensors, and collect data while performing ROBoT-r and postural sway tasks, with instructor supervision throughout.
ROBoT Docking: Participants will perform ROBoT-r training via our published approach 5, including instruction on (i) system components, (ii) performance criteria, and (iii) basic troubleshooting. During training sessions, participants will deploy ROBoT-r and perform a full session (12 runs) while standing on a posturography platform and wearing NINscan.
Postural Sway: During familiarization, participants will learn to safely maintain upright stance on a Zibrio-Pro (Zibrio, Houston, TX) computerized posturography platform. This will involve standing upright with head erect, arms next to their body, with their feet on the platform at shoulder width. The subjects will then be familiarized with the vestibular challenges: (1) performance of ±20⁰ dynamic head pitch-tilt oscillations at 0.33 Hz paced by an audible tone 12, 13, (2) viewing the circularly-rotating visual stimulus and reporting vection sensations, and (3) the Galvanic vestibular stimulation system. The Training sessions will not involve any vestibular challenges, just practice with the balance/posturography testing.
Phase 1: On-Ground (Preflight) Baseline Data Collection Ground Baseline Data Collection (BDC): After training, participants will participate in three baseline data collection procedures, spread over 3 days to minimize interference effects. Each session will include a rest recording, postural sway, docking, and one of our three neurovestibular challenges (counterbalanced to minimize potential order effects).
BDC Rest Recording: Each participant will fill out the Motion Sickness Susceptibility Questionnaire (MSSQ) first 3. They will then self-deploy the NINscan recording device (with experimenter oversight) to wear throughout the BDC period, starting with a 10-min rest recording.
BDC Postural Sway: Participants will then perform the postural sway task (above), using NINscan while standing on the computerized posturography platform to obtain baseline sway at 1g.
BDC Docking: Next, participants will perform a set of 12 ROBoT-r runs. Brief rest periods will occur between runs. This will provide baseline data on operationally relevant task performance in 1g.
BDC Neurovestibular Challenges: For our predictive models (Aim 3), the investigators will assess participants' preflight responses to three neurovestibular challenges, each based on a distinct type of sensory input. NINscan recordings will record throughout each exposure period. Challenges will be provided on each of 3 consecutive days, in counterbalanced orders. A Likert-style motion sickness scale (0-10) will be used to assess acute symptoms 11, while the Motion Sickness Symptoms Questionnaire (MSSQ) will be administered before and after each data collection session. All vestibular challenges will be performed while standing on the Zibrio posturography plate. Postural Sway recordings will start 2 min prior to vestibular challenges, and continue until 2 min after completion of challenges, each as described below.
- Galvanic vestibular stimulation (GVS) and adaptation (electrical input) 1, 8, 9. Participants standing on the posturography platform will undergo 25s periods of GVS over the mastoid processes (interleaved with rest periods) using a pseudorandom current waveform stimulus consisting of a sum-of-sines (0.16, 0.33, 0.43, 0.61 Hz) with a peak amplitude of 5 mA. These parameters are designed to replicate the postflight sensorimotor experience of astronauts 1. Three cycles of twelve alternations will be presented every 15 minutes for a total of 45 minutes to assess adaptation.
- Roll-vection and adaptation (visual input, non-otolith) 10, 15, 23. Standing subjects will view a central fixation cross on a computer monitor. A sparse field of stars will be rotated around the central point (60 deg/s), while the stars themselves rotate in the same direction to enhance the vection effect (60 deg/s) 10. Participants press a key whenever vection (self-rotation in the opposite direction of the visual stimulus) is perceived, and release it when the perception ceases 10. Stimulus periods will be 25s long, interleaved with 25s periods of a blank screen. During the blank screens, participants will verbally report the strength of the vection perception on a 0-100 scale (0=none, 50=the same vection as perceived in an initial, pretest single exposure to a globally-rotating stimulus 10). Again, three cycles of twelve stimulus/blank exposures will be presented every 15 minutes for a total of 45 minutes to assess adaptation.
- Oscillatory head pitch (mechanical input) 12, 13. Standing participants will either hold their head erect and static (HS), or perform continuous ±20 dynamic pitch oscillations (head dynamic, HD) at 0.33 Hz paced by an audible tone transmitted through lightweight headphones. White noise supplied through headphones will mask external auditory orientation cues. Three cycles of 12 HS and HD alternations will be performed during 45 minutes to assess adaptation.
Phase 2: Flight Data Collection
Flight testing: On flight day, participants will be pre-instrumented on the ground for rapid NINscan deployment. Anti-motion sickness medication will not be allowed for these participants, as it interferes with the neurovestibular measurements the investigators are making. Participants board the Airbus A310 ZERO-G and fasten seatbelts for takeoff. After takeoff, the pilots fly the aircraft to a specific air zone where the parabolas will take place. With other members of the participant's group and the instructor, participants will then move to the area of the cabin. Participants will receive instructions from Novespace to maintain safety during the parabolic flight. Upon reaching level flight, participants will don NINscan, start NINscan recording, and initialize the ROBoT-r equipment. Each participant will stand on a computerized posturography platform and perform two tasks during the 10 parabolas at each gravitational load (and for equivalent time periods during level flight at 1g): (1) operationally-relevant ROBoT-r task for the first 7 parabolas, and (2) postural sway assessment on the last 3 parabolas. As currently scheduled, there will be two flights for each participant. The first flight will include all n=12 participants and fly 31 parabolas, the first of which is for general orientation. Groups of 4 subjects will simultaneously perform the described tasks for 10 parabolas, and then they will switch places with the next group of 4 subjects. On the second flight for each participant, the plane will fly 31 parabolas again, the first being for orientation. After that, 3 sets of 10 parabolas will be flown, each set at a different gravity level (nominally 0.25, 0.5 and 0.75g). Participants will perform tasks during all three groups of 10 parabolas, identical to the 10 parabolas at 0. An additional period of level flight will be performed where participants again perform the same tasks on the same timeline, but at 1g. Participants will be closely monitored throughout by a dedicated experimenter and/or harnessed (as required by Novespace) to ensure safety.
If a participants agrees to the photo/video clause in the informed consent, photos/videos of their participation may be conducted during the flight. These will either be taken from behind the participant, or any facial features will be blurred and prior to use in any presentation or publication form.
There will be no post-flight activities for the participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study arm | Experimental | Other: Parabolic flightAll subjects perform the same activities (described in the protocol), but in different orders for counterbalancing purposes. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy 30-55-year-olds
- Willingness and ability to participate in flights without motion sickness medications.
- Any Novespace requirements
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Parabolic flightAlso: Galvanic vestibular stimulation, Vection, Head tiltsPreflight 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). | Other | Main study arm |
Primary outcome
ROBoT-r
Time frame: 10 days
Operationally-relevant track-and capture behavioral measures
Postural stability
Time frame: 10 days
Operationally-relevant standing balance measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Yes. All IPD from this project will be anonymized IPD and shared. Data will be coded with a key only available to the Principal Investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parabolic flight in people with Physiological Stress, run by Massachusetts General Hospital at 1 site in France.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 17 Dec 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ROBoT-r (time frame: 10 days). The study lists 2 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 17 Dec 2024.