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Clinical Trials/NCT02960243
NCT02960243
Completed
Not Applicable

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

University of British Columbia1 site in 1 country6 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Essential Voice Tremor
Sponsor
University of British Columbia
Enrollment
6
Locations
1
Primary Endpoint
The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Honey

Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

University of British Columbia

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Voice Tremor Severity(Measured every 3 minutes for 15 minutes)

Study Sites (1)

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