Dizziness, Vertigo
Conditions
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.
Interventions
DRUGPentoxifylline
Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
DRUGPlacebo
Patients will take placebo 3 times per day for 12 weeks
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pentoxifylline Pentoxifylline: Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks | 7 |
| Placebo Placebo: Patients will take placebo 3 times per day for 12 weeks | 13 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Pentoxifylline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 10 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 18 Participants |
| Region of Enrollment United States | 7 participants | 13 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 13 |
| other Total, other adverse events | 0 / 7 | 0 / 13 |
| serious Total, serious adverse events | 0 / 7 | 0 / 13 |
Outcome results
Primary
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
Population: Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on the Dizziness Handicap Inventory
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pentoxifylline | Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale | Baseline DHI | 46.57 Score on a scale | Standard Deviation 16.236 |
| Pentoxifylline | Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale | End of Treatment DHI | 36.57 Score on a scale | Standard Deviation 20.582 |
| Placebo | Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale | Baseline DHI | 53.85 Score on a scale | Standard Deviation 22.825 |
| Placebo | Effect of Trental Treatment Using the Dizziness Handicap Inventory, Vestibular Activities and Participation, and European Evaluation of Vertigo Scale | End of Treatment DHI | 42.83 Score on a scale | Standard Deviation 22.262 |
Primary
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
Population: Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on the European Evaluation of Vertigo scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Duration of Illusion | 2.00 units on a scale | Standard Deviation 1.291 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | End of Treatment EEV - Neurovegetative | 0 units on a scale | Standard Deviation 0 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Motion Intolerance | 0.86 units on a scale | Standard Deviation 1.464 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Instability | 2.29 units on a scale | Standard Deviation 0.756 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | End of Treatment (EOT) - Illusion of movement | 1.57 units on a scale | Standard Deviation 1.272 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | EOT - Instability | 1.0 units on a scale | Standard Deviation 0.816 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | End of Treatment EEV - Motion Intolerance | 0.57 units on a scale | Standard Deviation 1.134 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | EOT EEV - Duration of Illusion | 1.43 units on a scale | Standard Deviation 0.787 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Neurovegetative | 0.14 units on a scale | Standard Deviation 0.378 |
| Pentoxifylline | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Illusion of Movement | 2.00 units on a scale | Standard Deviation 1.155 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Neurovegetative | 0.92 units on a scale | Standard Deviation 1.256 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Illusion of Movement | 2.62 units on a scale | Standard Deviation 0.768 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | End of Treatment (EOT) - Illusion of movement | 1.55 units on a scale | Standard Deviation 1.128 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Duration of Illusion | 2.46 units on a scale | Standard Deviation 1.127 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | EOT EEV - Duration of Illusion | 1.64 units on a scale | Standard Deviation 1.206 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Motion Intolerance | 0.69 units on a scale | Standard Deviation 0.947 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | End of Treatment EEV - Motion Intolerance | 0.55 units on a scale | Standard Deviation 0.934 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | End of Treatment EEV - Neurovegetative | 0.45 units on a scale | Standard Deviation 1.036 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | Baseline EEV - Instability | 2.46 units on a scale | Standard Deviation 0.776 |
| Placebo | Effect of Trental Treatment Using the European Evaluation of Vertigo Scale | EOT - Instability | 1.145 units on a scale | Standard Deviation 0.82 |
Primary
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
Population: Determine the effect of 12 weeks of Trental compared to Placebo in patients with reported dizziness on Vestibular Activities and participation survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pentoxifylline | Effect of Trental Treatment Using the Vestibular Activities and Participation Survey | Baseline VAP | 1.487 score on a scale | Standard Deviation 0.5914 |
| Pentoxifylline | Effect of Trental Treatment Using the Vestibular Activities and Participation Survey | End of treatment VAP | 1.12 score on a scale | Standard Deviation 0.642 |
| Placebo | Effect of Trental Treatment Using the Vestibular Activities and Participation Survey | Baseline VAP | 1.405 score on a scale | Standard Deviation 0.5894 |
| Placebo | Effect of Trental Treatment Using the Vestibular Activities and Participation Survey | End of treatment VAP | 1.02 score on a scale | Standard Deviation 0.809 |