Drug Reaction Clinical Trial
Official title:
Motion Sickness Medications and Vestibular Time Constant
Sea sickness represents a major limitation on the performance of ships' crew. One of the
challenges faced by the physician in the motion sickness clinic when prescribing anti-sea
sickness medication is to select the appropriate drug for the patient. Difficulties arise due
to high variability in the response to different drugs. In the case of sea sickness, the
current procedure is to examine the drug's efficacy in each individual during real time
exposure to sea conditions.
A number of studies have documented the presence of sea sickness drug receptors in the
vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular
tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of
the proposed study is to evaluate the influence of motion sickness drugs on the vestibular
time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty
crew members will be recruited and divided into groups responsive and non-responsive to the
sea sickness drugs scopolamine and meclizine.
Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no
improvement in symptoms after treatment will be defined as non-responsive to sea sickness
drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a
Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.
Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind
fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours
after drug or placebo administration.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness - 48 hours prior to session without any use of medications - Soldiers who vomit in waves 1.5 meter high without drugs treatment Exclusion Criteria: - Anamnestic hearing Impairment - Ear infection of any kind - Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment. - Vision pathologies the interfere with VNG test. - Withdrawal of informed consent by the patient of any cause. |
Country | Name | City | State |
---|---|---|---|
Israel | Israeli Navy Medical Institute | Haifa |
Lead Sponsor | Collaborator |
---|---|
Medical Corps, Israel Defense Force |
Israel,
Bar R, Gil A, Tal D. Safety of double-dose transdermal scopolamine. Pharmacotherapy. 2009 Sep;29(9):1082-8. doi: 10.1592/phco.29.9.1082. — View Citation
Cheung BS, Howard IP, Money KE. Visually-induced sickness in normal and bilaterally labyrinthine-defective subjects. Aviat Space Environ Med. 1991 Jun;62(6):527-31. — View Citation
Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2. — View Citation
Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163. Review. — View Citation
Ishiyama A, López I, Wackym PA. Molecular characterization of muscarinic receptors in the human vestibular periphery. Implications for pharmacotherapy. Am J Otol. 1997 Sep;18(5):648-54. — View Citation
Phelan KD, Nakamura J, Gallagher JP. Histamine depolarizes rat medial vestibular nucleus neurons recorded intracellularly in vitro. Neurosci Lett. 1990 Feb 16;109(3):287-92. — View Citation
Pyykkö I, Schalén L, Matsuoka I. Transdermally administered scopolamine vs. dimenhydrinate. II. Effect on different types of nystagmus. Acta Otolaryngol. 1985 May-Jun;99(5-6):597-604. — View Citation
Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vestibular Time Constant Change/differential | One of the parameters measured in step velocity test [Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Step Velocity Test Gain Change/differential | One of the parameters measured in step velocity test [0-1] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Optokinetic After Nystagmus (OKAN) Gain Change/differential | One of the parameters measured in optokinetic test [0-1] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Optokinetic After Nystagmus (OKAN) Time Constant Change/differential | One of the parameters measured in optokinetic test [Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential | One of the parameters measured in optokinetic test [Deg/Sec] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Pupil Size Change/differential | Using pupil size chart [Mm] | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Pupil Accommodation and Convergation Change/differential | Eye test for drugs side effects. | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. | |
Primary | Side Effects Questionnaire Change/differential | Questionnaire of drugs' side effects. | Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator. |
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