Using intranasal scopolamine and sensory feedback to reduce motion sickness and improve performance

Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance

This study is testing if a nasal gel combined with sensory feedback can help people feel less motion sickness and perform better when exposed to simulated wave motion.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Repurposed Therapeutics, Inc. (industry)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05886660 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of intranasal scopolamine gel combined with sensory augmentation to reduce motion sickness and enhance sensorimotor performance. Participants will be exposed to simulated wave motion on a 6DOF platform while receiving either the scopolamine gel or a placebo, with and without sensory feedback from a vibrotactile belt. The study employs a randomized double-blind cross-over design to compare the severity of motion sickness symptoms and performance outcomes across four different conditions. The goal is to determine if the combination of these interventions is more effective than either intervention alone.

Who should consider this trial

Good fit: Ideal candidates are individuals who are minimally susceptible to motion sickness but experience symptoms under certain conditions.

Not a fit: Patients with neurological, vestibular, or autonomic disorders, or those who are hypersensitive to scopolamine, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly alleviate motion sickness and improve performance in environments where motion sickness is a concern, such as space travel or maritime activities.

How similar studies have performed: While the combination of these specific interventions is novel, previous studies have shown that both intranasal scopolamine and sensory augmentation can be effective in mitigating motion sickness.

Eligibility criteria

Inclusion Criteria:

1. Subjects should be minimally susceptible to provocative motion as evidenced by at least two responses on the Motion Sickness Susceptibility Questionnaire of "Sometimes" or "Frequently."
2. No participants should have neurologic, vestibular or autonomic disorders, or medical conditions that could be worsened by scopolamine (narrow-angle glaucoma or urinary retention
3. Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) negative test, confirmed by Food and Drug Administration (FDA) authorized COVID-19 test \< 7 days prior to study drug administration or no COVID 19 symptoms up to 10 days prior to study drug administration.

Exclusion Criteria:

1. Subjects will be excluded if they are taking other drugs that are capable of causing CNS effects such as antihistamines, tricyclic antidepressants, and muscle relaxants or have hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system.
2. Pregnant women are excluded from participation. Women of child-bearing potential will be offered a pregnancy screening test and excluded with a positive test.

Where this trial is running

Houston, Texas

• NASA Johnson Space Center Neuroscience Laboratory — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Scott J Wood, PhD — National Aeronautics and Space Administration (NASA)
• Study coordinator: Barry Feinberg, MD

Conditions: Motion Sickness, Space, Motion Sickness, Sea Sickness, wave motion, eye-hand coordination, artificial horizon