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

Primary Purpose

Vestibular

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Promethazine
Hyper gravity training
Placebo
No hypergravity training
Sponsored by
Faisal_Karmali@MEEI.HARVARD.EDU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vestibular

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Tilt perception, Training, placebo

Tilt perception, No training, placebo

Tilt perception, Training, promethazine

Tilt perception,No training,promethazine

Manual Control, Training, placebo

Manual Control, No training, placebo

Manual Control, Training, promethazine

Manual Control,No training,promethazine

Perceptual thresholds,drug then placebo

Perceptual thresholds,placebo then drug

Arm Description

placebo

subject does test with no hypergravity training and placebo drug only

promethazine 25 mg, one time 120 minutes prior to experiment

promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training

placebo

subject does test with no hyper gravity training and placebo drug only

promethazine 25 mg, one time 120 minutes prior to experiment

promethazine 25 mg, one time 120 minutes prior to experiment

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2014
Last Updated
December 7, 2017
Sponsor
Faisal_Karmali@MEEI.HARVARD.EDU
Collaborators
National Space Biomedical Research Institute, Massachusetts Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02136420
Brief Title
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Official Title
Countermeasures to Reduce Sensorimotor Impairment and Space Motion Sickness Resulting From Altered Gravity Levels
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Faisal_Karmali@MEEI.HARVARD.EDU
Collaborators
National Space Biomedical Research Institute, Massachusetts Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The design includes three separate studies: Arm 9&10 follows a crossover design. These results were reported in Diaz-Artiles et al 2017. 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. 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
ParticipantInvestigator
Masking Description
Double masking applies to arms 9&10. Other arms use participant masking only.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tilt perception, Training, placebo
Arm Type
Experimental
Arm Description
placebo
Arm Title
Tilt perception, No training, placebo
Arm Type
Placebo Comparator
Arm Description
subject does test with no hypergravity training and placebo drug only
Arm Title
Tilt perception, Training, promethazine
Arm Type
Experimental
Arm Description
promethazine 25 mg, one time 120 minutes prior to experiment
Arm Title
Tilt perception,No training,promethazine
Arm Type
Experimental
Arm Description
promethazine 25 mg, one time 120 minutes prior to experiment. No hypergravity training
Arm Title
Manual Control, Training, placebo
Arm Type
Experimental
Arm Description
placebo
Arm Title
Manual Control, No training, placebo
Arm Type
Placebo Comparator
Arm Description
subject does test with no hyper gravity training and placebo drug only
Arm Title
Manual Control, Training, promethazine
Arm Type
Experimental
Arm Description
promethazine 25 mg, one time 120 minutes prior to experiment
Arm Title
Manual Control,No training,promethazine
Arm Type
Experimental
Arm Description
promethazine 25 mg, one time 120 minutes prior to experiment
Arm Title
Perceptual thresholds,drug then placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Perceptual thresholds,placebo then drug
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Promethazine
Other Intervention Name(s)
Phenergan
Intervention Description
Subject receives promethazine
Intervention Type
Behavioral
Intervention Name(s)
Hyper gravity training
Intervention Description
Subject receives hypergravity training before testing
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
corn starch
Intervention Description
Placebo
Intervention Type
Behavioral
Intervention Name(s)
No hypergravity training
Intervention Description
Subjects do not receive normal Earth gravity
Primary Outcome Measure Information:
Title
Percent Change in Roll Tilt Perception After Exposure to Hypogravity
Description
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.
Time Frame
1 session
Title
Yaw Perceptual Motion Threshold
Description
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.
Time Frame
2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication
Title
Roll Perceptual Motion Threshold
Description
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.
Time Frame
2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication
Title
Interaural Perceptual Motion Threshold
Description
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.
Time Frame
2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication
Title
Percent Change in Manual Control Performance After Exposure to Hypogravity
Description
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.
Time Frame
1 session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Karmali, Ph.D.
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28439720
Citation
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.
Results Reference
result

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

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