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Clinical Trials/NCT02136420
NCT02136420
Completed
Phase 4

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

Faisal_Karmali@MEEI.HARVARD.EDU1 site in 1 country30 target enrollmentJune 2014

Overview

Phase
Phase 4
Intervention
Hyper gravity training
Conditions
Vestibular
Sponsor
Faisal_Karmali@MEEI.HARVARD.EDU
Enrollment
30
Locations
1
Primary Endpoint
Percent Change in Roll Tilt Perception After Exposure to Hypogravity
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Faisal_Karmali@MEEI.HARVARD.EDU
Responsible Party
Sponsor Investigator
Principal Investigator

Faisal_Karmali@MEEI.HARVARD.EDU

Primary Investigator

Massachusetts Eye and Ear Infirmary

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

Arms & Interventions

Tilt perception, Training, placebo

placebo

Intervention: Hyper gravity training

Tilt perception, Training, placebo

placebo

Intervention: Placebo

Tilt perception, No training, placebo

subject does test with no hypergravity training and placebo drug only

Intervention: Placebo

Tilt perception, No training, placebo

subject does test with no hypergravity training and placebo drug only

Intervention: No hypergravity training

Tilt perception, Training, promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Intervention: Promethazine

Tilt perception, Training, promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Intervention: Hyper gravity training

Tilt perception,No training,promethazine

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

Intervention: Promethazine

Tilt perception,No training,promethazine

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

Intervention: No hypergravity training

Manual Control, Training, placebo

placebo

Intervention: Hyper gravity training

Manual Control, Training, placebo

placebo

Intervention: Placebo

Manual Control, No training, placebo

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

Intervention: Placebo

Manual Control, No training, placebo

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

Intervention: No hypergravity training

Manual Control, Training, promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Intervention: Promethazine

Manual Control, Training, promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Intervention: Hyper gravity training

Manual Control,No training,promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Intervention: Promethazine

Manual Control,No training,promethazine

promethazine 25 mg, one time 120 minutes prior to experiment

Intervention: No hypergravity training

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.

Intervention: Promethazine

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.

Intervention: Placebo

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.

Intervention: Promethazine

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.

Intervention: Placebo

Outcomes

Primary Outcomes

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.

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.

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.

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.

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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