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Completed

NCT Number: NCT02960243

Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres?

Deep Brain Stimulation (DBS) is the gold standard treatment for Essential Tremor (ET). ET is a movement disorder which causes the arms, feet, fingers, head or voice to involuntarily shake. The DBS surgical procedure involves implanting an electrode deep within the brain which blocks damaging signals that cause the tremor. Essential Voice Tremor (EVT) is the vocal manifestation of ET and a number of individuals have both ET and EVT, and when these patients are implanted for their ET, their EVT symptoms are often also mitigated. This study aims to quantify the effects of DBS on EVT by testing on these ET+EVT patients. In addition to this, we hope to determine which hemisphere of the brain is responsible for larynx control: left or right.

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Key information

Conditions

Essential Voice Tremor Action Tremor Central Nervous System Diseases Deep Brain Stimulation Dyskinesias Essential Tremor Laryngeal Diseases Movement Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Tremor Tremor, Nerve

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

Essential Tremor (ET) is the most common movement disorder in adults, affecting approximately 5% of individuals over the age of 65. Of this 5%, roughly 20% of these patients suffer from Essential Voice Tremor (EVT): the phonatory manifestation of ET. Patients with EVT lose their ability to speak due to a tremor in the muscles of the larynx, pharynx, palate, and tongue. Because of this, an individual's quality of life is limited because they can no longer communicate effectively.

The purpose of this study is to quantify to what degree Deep Brain Stimulation improves Essential Voice Tremor. In addition to this, we hope to examine which brain hemisphere is responsible for these positive results: right, left, or both, in a prospective, randomized, double-blinded manner. By finding out more about the subcortical control underpinning speech, we will be able to improve our treatments and understanding of EVT and other neurological speech disorders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has been implanted with the DBS for ET
  • Participant has significant voice tremor as determined by our laryngology/speech-language pathology team

Exclusion criteria

  • Participant does not have history of aphasia or other speech/language deficits
  • Participant does not have history of stroke or multiple sclerosis

Treatment and study plan

Deep brain stimulation

Device
  • DBS System Medtronic
  • DBS programming settings will be set to maximally alleviate limb tremor, primary reason for referral
  • These settings will be used to evaluate effects of voice tremor as well

Other names: DBS

Primary outcomes

  1. The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

    Time frame: At the end of each trial period, typically 15 minutes after change in stimulation settings

    Patients will be asked to read a voice protocol designed to elicit voice tremor symptoms. This will be conducted at the end of every trial arm with a patient sitting in a rest position without moving upper or lower limbs.

Secondary outcomes

  1. Voice Tremor Severity

    Time frame: Measured every 3 minutes for 15 minutes

    At the end of the study, the kinetics of voice tremor and limb tremor will be analyzed to determine if there are any similarities or differences in the time course to deterioration

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Left, Right, or Bilateral Thalamic Deep Brain Stimulation for Voice Tremor: A Prospective, Randomized, Double-Blinded Trial

Acronym: EVT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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