Trental for the Treatment of Vertigo/Dizziness/Imbalance

University of Missouri-Columbia26 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dizziness Vertigo

Interventions

PentoxifyllineDRUG

Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks

PlaceboDRUG

Patients will take placebo 3 times per day for 12 weeks

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults 40 years and older 2. English as primary language 3. 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 4. Willingness to complete surveys and take medication as prescribed Exclusion Criteria: 1. Diagnosis of the following: benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine with headache, intracranial mass, perilymphatic fistula, or multiple sclerosis 2. history of cholesteatoma 3. Prior ear surgery other than myringotomy and tube placement 4. Prior radiation to head or neck 5. previous use of vestibulotoxic medications where the enrolling provider determines the drug exposure to be the cause of imbalance 6. Use of blood thinning medications 7. intolerance/allergy to pentoxifylline or methylxanthines, as well as recent cerebral or retinal hemorrhage (past 3 months) 8. Pregnant or lactating females.

Locations (1)

University of Missouri

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale

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.

Time frame: 12 weeks

Effect of Trental Treatment Using the European Evaluation of Vertigo Scale

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)

Time frame: 12 Weeks

Effect of Trental Treatment Using the Vestibular Activities and Participation Survey

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.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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