N/A
N=134
Vestibular Consequences of Blast-related Mild Traumatic Brain Injury (TBI)
Dizziness · Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01021137 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Peripheral Vestibular Function (Vestibulo-ocular Reflex/Semicircular Canal): Caloric Weakness — 8.8; 14.7; 12.3; 7.1 percentage of caloric weakness
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Vestibular Function (Vestibulo-ocular Reflex/Semicircular Canal): Caloric Weakness |
8.8; 14.7; 12.3; 7.1 | — |
| PRIMARY Rotary Chair Slow Harmonic Acceleration (SHA) Gain |
.4; .4; .4; .4 | — |
| PRIMARY Peripheral Vestibular Function (Saccular-collic Pathway): Cervical Vestibular Evoked Potential (cVEMP) |
26.1; 31.2; 45.1; 20.1 | — |
| PRIMARY Rotary Chair Slow Harmonic Acceleration (SHA) Phase |
41.3; 40.1; 40.1; 42.2 | — |
| PRIMARY Peripheral Vestibular Function (Utricular-ocular Pathway): Ocular Vestibular Evoked Potential (oVEMP) |
22.0; 15.7; 39.1; 18.0 | — |
| SECONDARY Central Vestibular/Central Nervous System (CNS) Function: Visual Fixation Suppression |
0.069; 0.058; 0.059; 0.065 | — |
| SECONDARY Postural Stability: Sensory Organization Test (SOT) |
65; 62; 61; 81 | — |
| SECONDARY Dizziness Handicap Inventory |
48.7; 48.6; 41.6; 0 | — |
Summary
The purpose of this project is to determine the effects of mild traumatic brain injury and blast exposure on the inner ear balance and central nervous systems.
Eligibility Criteria
Inclusion Criteria
- Complaint of dizziness and/or imbalance
- History of blast exposure
- Diagnosis of mild traumatic brain injury
Exclusion Criteria
- Prior history of vestibular or neurological disorder
- Presence of internal metal
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01021137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.