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| Name | Class |
|---|---|
| National Space Biomedical Research Institute | OTHER |
| Massachusetts Institute of Technology | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilt perception, Training, placebo | Experimental | placebo |
|
| Tilt perception, No training, placebo | Placebo Comparator | subject does test with no hypergravity training and placebo drug only |
|
| Tilt perception, Training, promethazine | Experimental | promethazine 25 mg, one time 120 minutes prior to experiment |
|
| Tilt perception,No training,promethazine | Experimental | promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training |
|
| Manual Control, Training, placebo | Experimental | placebo |
|
| Manual Control, No training, placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promethazine | Drug | Subject receives promethazine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Roll Tilt Perception After Exposure to Hypogravity | 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. | 1 session |
| Yaw Perceptual Motion Threshold | 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. | 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication |
| Roll Perceptual Motion Threshold | 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. | 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faisal Karmali, Ph.D. | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28439720 | Result | Diaz-Artiles A, Priesol AJ, Clark TK, Sherwood DP, Oman CM, Young LR, Karmali F. The Impact of Oral Promethazine on Human Whole-Body Motion Perceptual Thresholds. J Assoc Res Otolaryngol. 2017 Aug;18(4):581-590. doi: 10.1007/s10162-017-0622-z. Epub 2017 Apr 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tilt Perception, Training, Placebo | placebo |
| FG001 | Tilt Perception, No Training, Placebo | subject does test with no hypergravity training and placebo drug only |
| FG002 | Tilt Perception, Training, Promethazine | promethazine 25 mg, one time 120 minutes prior to experiment |
| FG003 | Tilt Perception,No Training,Promethazine | promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training |
| FG004 | Manual Control, Training, Placebo | placebo |
| FG005 | Manual Control, No Training, Placebo | subject does test with no hyper gravity training and placebo drug only |
| FG006 | Manual Control, Training, Promethazine | promethazine 25 mg, one time 120 minutes prior to experiment |
| FG007 | Manual Control,No Training,Promethazine | promethazine 25 mg, one time 120 minutes prior to experiment |
| FG008 | 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. |
| FG009 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tilt Perception, Training, Placebo | placebo Hyper gravity training: Subject receives hypergravity training before testing Placebo: Placebo |
| BG001 | Manual Control, Training, Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Roll Tilt Perception After Exposure to Hypogravity | 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. | Posted | Mean | Full Range | percentage change | 1 session |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tilt Perception, Training, Placebo | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Faisal Karmali | Massachusetts Eye and Ear Infirmary | 617-573-5593 | faisal_karmali@meei.harvard.edu |
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| ID | Term |
|---|---|
| D011398 | Promethazine |
| D013213 | Starch |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
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The design includes three separate studies:
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Double masking applies to arms 9&10. Other arms use participant masking only.
| Placebo Comparator |
subject does test with no hyper gravity training and placebo drug only |
|
| Manual Control, Training, promethazine | Experimental | promethazine 25 mg, one time 120 minutes prior to experiment |
|
| Manual Control,No training,promethazine | Experimental | promethazine 25 mg, one time 120 minutes prior to experiment |
|
| Perceptual thresholds,drug then placebo | Experimental | 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. |
|
| Perceptual thresholds,placebo then drug | Experimental | 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. |
|
|
| Hyper gravity training | Behavioral | Subject receives hypergravity training before testing |
|
| Placebo | Drug | Placebo |
|
|
| No hypergravity training | Behavioral | Subjects do not receive normal Earth gravity |
|
| Interaural Perceptual Motion Threshold | 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. | 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication |
| Percent Change in Manual Control Performance After Exposure to Hypogravity | 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. | 1 session |
placebo
Hyper gravity training: Subject receives hypergravity training before testing
Placebo: Placebo
| BG002 | 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. Promethazine: Subject receives promethazine Placebo: Placebo |
| BG003 | 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. Promethazine: Subject receives promethazine Placebo: Placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Yaw Perceptual Motion Threshold | 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. | Posted | Geometric Mean | Standard Deviation | deg per sec | 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication |
|
|
|
| Primary | Roll Perceptual Motion Threshold | 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. | Posted | Geometric Mean | Standard Deviation | deg per sec | 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication |
|
|
|
| Primary | Interaural Perceptual Motion Threshold | 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. | Posted | Geometric Mean | Standard Deviation | cm per sec | 2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication |
|
|
|
| Primary | Percent Change in Manual Control Performance After Exposure to Hypogravity | 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. | Posted | Mean | Standard Deviation | percentage change | 1 session |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Tilt Perception, No Training, Placebo | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Tilt Perception, Training, Promethazine | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Tilt Perception, No Training, Promethazine | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Perceptual Threshold Testing: Promethazine | 0 | 10 | 0 | 10 | 0 | 10 |
| EG005 | Perceptual Motion Threshold Testing: Placebo | 0 | 10 | 0 | 10 | 0 | 10 |
| EG006 | Manual Control, Training, Placebo | 0 | 10 | 0 | 10 | 0 | 10 |
| EG007 | Manual Control, No Training, Placebo | 0 | 0 | 0 | 0 | 0 | 0 |
| EG008 | Manual Control, Training, Promethazine | 0 | 0 | 0 | 0 | 0 | 0 |
| EG009 | Manual Control, No Training, Promethazine | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013457 |
| Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |