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Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels

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ClinicalTrials.gov Identifier: NCT02136420
Recruitment Status : Completed
First Posted : May 13, 2014
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Collaborators:
National Space Biomedical Research Institute
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Faisal_Karmali@MEEI.HARVARD.EDU, Massachusetts Eye and Ear Infirmary

Brief Summary:
The investigators will study adaptation of motion perception and manual control in altered gravity, including the effects of a drug (promethazine). The investigators will also study whether promethazine affects motion perceptual thresholds.

Condition or disease Intervention/treatment Phase
Vestibular Drug: Promethazine Behavioral: Hyper gravity training Drug: Placebo Behavioral: No hypergravity training Phase 4

Detailed Description:
Adaptation to altered gravity has been of concern from the earliest reports of space motion sickness, through the Apollo exploration era, and into current planning of exploration missions. The proposed research program takes a new approach which could lead to an effective, practical and acceptable protocol for preadapting astronauts to space flight. By using the gravito-inertial alterations possible with centrifugation in different body orientations the investigators will quantify an individual's sensory adaptation capability and use it to predict and to minimize the consequences of movement in any other gravity environment - eventually including weightlessness. The investigators will also study whether a drug (promethazine) affects motion perception and motion sickness.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

The design includes three separate studies:

  1. Arm 9&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017.
  2. Arms 1-4 are a separate study which follow a factorial design, with arm 2 serving as the placebo, arms 1 and 3 assessing the effects of two separate interventions and arm 4 assessing the effect of two combined interventions.
  3. Arms 5-8 are a separate study which follow a factorial design, with arm 6 serving as the placebo, arms 5 and 7 assessing the effects of two separate interventions and arm 8 assessing the effect of two combined interventions.
Masking: Double (Participant, Investigator)
Masking Description: Double masking applies to arms 9&10. Other arms use participant masking only.
Primary Purpose: Basic Science
Official Title: Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Study Start Date : June 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Tilt perception, Training, placebo
placebo
Behavioral: Hyper gravity training
Subject receives hypergravity training before testing

Drug: Placebo
Placebo
Other Name: corn starch

Placebo Comparator: Tilt perception, No training, placebo
subject does test with no hypergravity training and placebo drug only
Drug: Placebo
Placebo
Other Name: corn starch

Behavioral: No hypergravity training
Subjects do not receive normal Earth gravity

Experimental: Tilt perception, Training, promethazine
promethazine 25 mg, one time 120 minutes prior to experiment
Drug: Promethazine
Subject receives promethazine
Other Name: Phenergan

Behavioral: Hyper gravity training
Subject receives hypergravity training before testing

Experimental: Tilt perception,No training,promethazine
promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training
Drug: Promethazine
Subject receives promethazine
Other Name: Phenergan

Behavioral: No hypergravity training
Subjects do not receive normal Earth gravity

Experimental: Manual Control, Training, placebo
placebo
Behavioral: Hyper gravity training
Subject receives hypergravity training before testing

Drug: Placebo
Placebo
Other Name: corn starch

Placebo Comparator: Manual Control, No training, placebo
subject does test with no hyper gravity training and placebo drug only
Drug: Placebo
Placebo
Other Name: corn starch

Behavioral: No hypergravity training
Subjects do not receive normal Earth gravity

Experimental: Manual Control, Training, promethazine
promethazine 25 mg, one time 120 minutes prior to experiment
Drug: Promethazine
Subject receives promethazine
Other Name: Phenergan

Behavioral: Hyper gravity training
Subject receives hypergravity training before testing

Experimental: Manual Control,No training,promethazine
promethazine 25 mg, one time 120 minutes prior to experiment
Drug: Promethazine
Subject receives promethazine
Other Name: Phenergan

Behavioral: No hypergravity training
Subjects do not receive normal Earth gravity

Experimental: Perceptual thresholds,drug then placebo

Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with promethazine then once with placebo, separated by >4 days.

This arm corresponds to results published in Diaz-Artiles et al 2017.

Drug: Promethazine
Subject receives promethazine
Other Name: Phenergan

Drug: Placebo
Placebo
Other Name: corn starch

Experimental: Perceptual thresholds,placebo then drug

Subjects undergo perceptual motion threshold tests to determine the smallest motion they can reliably sense for yaw rotation, interaural translation and roll tilt. Each subject is tested twice, once with placebo then once with promethazine, separated by >4 days.

This arm corresponds to results published in Diaz-Artiles et al 2017.

Drug: Promethazine
Subject receives promethazine
Other Name: Phenergan

Drug: Placebo
Placebo
Other Name: corn starch




Primary Outcome Measures :
  1. Percent Change in Roll Tilt Perception After Exposure to Hypogravity [ Time Frame: 1 session ]

    Note that this applies to arms 1-4 only.

    Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects were repeatedly roll tilted to angles between 11 and 19 degrees, and then reported their perceived tilt angle using a subjective visual vertical task. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We hypothesized that, after entering hypogravity, subjects would tend to underestimate their tilt angle. We calculated the percent change in their perception of tilt between 1 Gz and 0.5 Gz.


  2. Yaw Perceptual Motion Threshold [ Time Frame: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication ]

    This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Yaw rotation means rotations about an axis that is perpendicular to gravity.

    This outcome measure applies only to arm 5 subjects.


  3. Roll Perceptual Motion Threshold [ Time Frame: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication ]

    This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Roll tilt means rotations about an axis that is Earth-horizontal.

    This outcome measure applies only to arm 5 subjects.


  4. Interaural Perceptual Motion Threshold [ Time Frame: 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication ]

    This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Interaural translation refers to translations in the horizontal plane to the subject's left or right.

    This outcome measure applies only to arm 5 subjects.


  5. Percent Change in Manual Control Performance After Exposure to Hypogravity [ Time Frame: 1 session ]

    Note that this applies to arms 6-9 only.

    Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects completed a manual control task in which their charge was randomly perturbed in roll tilt, and they used a joystick to attempt to keep themselves aligned with upright, while in the dark. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We calculated their performance by calculating the standard deviation of chair position across time, with a smaller number indicating better performance. Then we calculated the percent change in their performance between 1 Gz and 0.5 Gz.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be in general good health

Exclusion Criteria:

  • Anyone who is not generally in good general health does not qualify
  • Cardiovascular disease
  • Severe diabetes
  • Respiratory condition (e.g. asthma or emphysema)
  • Narrow angle glaucoma
  • Prostatic hypertrophy
  • Gastrointestinal disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136420


Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Faisal_Karmali@MEEI.HARVARD.EDU
National Space Biomedical Research Institute
Massachusetts Institute of Technology
Investigators
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Principal Investigator: Faisal Karmali, Ph.D. Massachusetts Eye and Ear Infirmary
Publications of Results:
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Responsible Party: Faisal_Karmali@MEEI.HARVARD.EDU, Primary Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02136420    
Other Study ID Numbers: 497997
First Posted: May 13, 2014    Key Record Dates
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Motion Sickness
Space Motion Sickness
Promethazine
Diphenhydramine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents