A Study of Factors That Predispose, Promote, and Perpetuate Post-Traumatic Dizziness

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-008679
    Sponsor Protocol Number: W81XWH-17-CTRR-CRA PT170028

About this study

The purpose of this study is to investigate whether recent, groundbreaking discoveries about key pathophysiologic processes that drive chronic dizziness in patients without traumatic brain injury (TBI9,10) are applicable to patients with post-mTBI vestibular disability. We expect the results of this project to have practical clinical and research applications, providing novel data for two future steps:

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Men and women, age 18-50 years old.
  • Right-hand dominated.
  • Vestibular symptoms of moderate or greater severityb after a verified mTBI:
    • Vertigo, unsteadiness, dizziness, or gait imbalance;
    • mTBI per Table 1 of the VA/DoD mTBI guideline;
    • Enrolled within 8 weeks of mTBI (Rochester, London);
    • Enrolled within 6 months of mTBI (Rome).

Exclusion Criteria:

  • Medical or psychiatric conditions, medications, or substances that would limit a participant’s ability to provide consent or complete all study procedures
  • Metal in the body that is not compatible with MRI.
  • Active tobacco usage.
  • Pregnant or breast-feeding.
  • Neurologic, otologic, or psychiatric disorders, pre-dating injury.
  • Any history of neurologic, otologic, or psychiatric disorders.
  • Any history of symptomatic TBI.
  • Changes in neurologic or psychiatric medications within 2 weeks of fMRI.
  • Use of neurological or psychiatric medications.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Staab, M.D.

Open for enrollment

Contact information:

Michelle Skime M.S., CCRP

(507)255-0501

Skime.Michelle@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20449554

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