Trental for the Treatment of Vertigo/Dizziness/Imbalance

Not Applicable

Terminated

Conditions: Dizziness
Vertigo

Interventions: Drug: Placebo
Drug: Pentoxifylline

Registration Number: NCT02592863

Lead Sponsor: University of Missouri-Columbia

Brief Summary: Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symptoms have a severe impact on affected individuals with detrimental effects on work, travel, social and family life. These patients see doctors often with no relief in their symptoms.

The most promising help for these patients is to use medication that will increase blood flow to the inner ear. Pentoxifylline (Trental) has been shown to increase microvascular blood flow.

Detailed Description: One potential cause of vestibular dysfunction is a decrease in or insufficient blood flow to the inner ear. Studies have shown that when the blood flow is decreased to the inner ear, patients will become dizzy and off balance. This study will use validated instruments to evaluate the effectiveness of Trental in patients that present to our providers with vertigo, dizziness, or imbalance and meet inclusion criteria. They will be blinded and randomized to treatment or placebo, which they will take for \~12 weeks. Patients will completed validated surveys 3 times (beginning, middle and end of study) as well as account for the number of times they have fallen and if they have missed any work due to their symptoms.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 26

Inclusion Criteria

Adults 40 years and older
English as primary language
Diagnosis of multisensory losses, presbystasis, bilateral vestibulopathy, central vascular insufficiency, small vessel circulatory disease, generalized imbalance, and idiopathic peripheral vertigo scoring at least 16 on the Dizziness Handicap Inventory
Willingness to complete surveys and take medication as prescribed

Exclusion Criteria

Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis
history of cholesteatoma
Prior ear surgery other than myringotomy and tube placement
Prior radiation to head or neck
previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance
Use of blood thinning medications
intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral or retinal hemorrhage (past 3 months)
Pregnant or lactating females.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will take placebo 3 times per day for 12 weeks
Pentoxifylline	Pentoxifylline	Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale	12 weeks	The Dizziness Handicap Inventory (DHI) is 25 question self report questionnaire that measures how dizziness affects a person's daily life. The questions are grouped into three domains: physical (P), emotional (E), and functional (F). Each question has three possible answers: "Always", "Sometimes", or "No". The answers are worth points, with "Always" being worth 4 points, "Sometimes" worth 2 points, and "No" worth 0 points. After answering all the questions, the total score is calculated, ranging from 0 to 100 points. A higher score indicates a more severe handicap, with 0 points indicating no effect and 100 points indicating maximum effect.
Effect of Trental Treatment Using the European Evaluation of Vertigo Scale	12 Weeks	The European Evaluation of Vertigo scale (EEV) is a physician-administered questionnaire that only assesses symptoms of the vestibular syndrome: illusion of movement, duration of illusion, motion intolerance, neurovegetative signs, and instability. The symptoms are ranked on a scale of 0 (no problem) to 4 (severe problem) and each area of assessment is stand alone (meaning the scores from each area to do not combine to create one larger score)
Effect of Trental Treatment Using the Vestibular Activities and Participation Survey	12 Weeks	Vestibular Activities and Participation (VAP) is 34-item self-report tool that measures the extent of activity limitations and participation restrictions caused by vestibular disorders. The VAP can be used for assessment, intervention planning, outcome evaluation, and to reflect a patient's status. Answers are ranked on a likert scale where 0 is no problem and 4 is unable to do. Scores are averaged and the higher the score the worse the problem, such that 0 is no problem and 54 or great is a severe problem.