Effects of Octanoic Acid for Treatment of Essential Voice Tremor
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Syracuse University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor
Study Overview
Brief Summary
Essential voice tremor is a neurological condition that produces a regular, shaking quality in the voice. One form of drug treatment that produces some improvement in tremor of the hands is octanoic acid, which is a food additive that is similar to alcohol. Research suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no intoxication effects. This study will determine whether octanoic acid may be useful for reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid will reduce the effects of tremor on the voice.
Detailed Description
Background:
- Essential tremor of the voice produces regular shaking and hoarseness in the voice, making it difficult speech difficult to understand
- Several previous studies have found that octanoic acid and octanol, which are related to alcohol, can improve tremor in some people without producing many side effects and without producing intoxication
- Researchers are interested in determining whether octanoic acid can improve tremor that affects the voice
Objectives:
- To determine the effects of octanoic voice using voice recordings and listener ratings of voice
- To determine the effects of octanoic acid on level of voice disability experienced by people with essential voice tremor
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment
- •Participants show measurable voice tremor from recordings of the voice during screening appointment
Exclusion Criteria
- •Participants have a diagnosis or show signs of Parkinson's Disease or another non-essential tremor movement disorder
- •Participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder)
- •Participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer
- •Participants have a diagnosis of diabetes mellitus
- •Participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study
- •Participants have a dependence on alcohol or allergy to alcohol
- •Participants are pregnant or lactating
- •Participants have an allergy to soy
- •Participants have Irritable Bowel Syndrome
Arms & Interventions
Inactive capsule
Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study.
Intervention: Inactive capsule (Drug)
Octanoic acid
Participants will receive a pill/capsule with octanoic acid (amount determined by the participant's weight) during the experimental arm of this study.
Intervention: Octanoic acid (Drug)
Outcomes
Primary Outcomes
Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor
Time Frame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2)
Voice recordings were used to measure the degree of tremor in the voice. Mean post-test values for each acoustic measure were compared after the octanoic acid and placebo conditions, with and without consideration of baseline values. Mean values represent the average of two testing days. Degree of amplitude tremor shows the extent of amplitude variation as a percent of the mean signal amplitude, with lower numbers indicating less amplitude tremor. Baseline values for magnitude of amplitude tremor across all participants and conditions ranged from 4.06 to 27.09, and post-test values ranged from 1.94 to 26.02. Degree of frequency tremor shows the extent of fundamental frequency variation as a percent of the mean signal frequency, with lower numbers indicating less frequency tremor. Baseline values for magnitude of frequency tremor across all participants and conditions ranged from 1.21 to 15.31, and post-test values ranged from 0.60 to 13.86.
Secondary Outcomes
- Auditory-perceptual Tremor Severity Ratings(Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2).)
Investigators
Soren Lowell
Assistant Professor, Communication Sciences & Disorders
Syracuse University