Trial record 2 of 38 for:    Open Studies | "Tremor"

Effects of Octanoic Acid for Treatment of Essential Voice Tremor

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Syracuse University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Soren Lowell, Syracuse University
ClinicalTrials.gov Identifier:
NCT01864525
First received: May 21, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Essential Voice Tremor
Vocal Tremor
Voice Tremor
Essential Tremor of Voice
Drug: Octanoic acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Syracuse University:

Primary Outcome Measures:
  • Pre- to post-treatment change in the acoustic characteristics of voice tremor [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Voice recordings will be used to measure the degree of tremor in the voice. Degree of change from pre- to post-treatment will be compared for the octanoic acid and placebo conditions.


Secondary Outcome Measures:
  • Pre- to post-treatment change in the auditory-perceptual characteristics of voice tremor [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Listeners will rate the voice from comparisons of recordings before and after each condition. Degree of change from pre- to post-treatment will be compared for the octanoic acid and placebo conditions.


Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inactive pill
Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study.
Experimental: 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.
Drug: Octanoic acid
Other Name: Caprylic acid

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
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864525

Contacts
Contact: Soren Y Lowell, PhD 315-443-9648 slowell@syr.edu

Locations
United States, New York
Syracuse University & Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Soren Y Lowell, PhD    315-443-9648    slowell@syr.edu   
Sponsors and Collaborators
Syracuse University
Investigators
Principal Investigator: Soren Y Lowell, PhD Syracuse University
  More Information

Publications:
Responsible Party: Soren Lowell, Assistant Professor, Communication Sciences & Disorders, Syracuse University
ClinicalTrials.gov Identifier: NCT01864525     History of Changes
Other Study ID Numbers: 370955-3, 1R03DC012429-01A1
Study First Received: May 21, 2013
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Syracuse University:
voice
tremor
essential tremor
essential voice tremor
voice treatment
octanoic acid
octanol
voice disorder
dysphonia

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014