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

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ClinicalTrials.gov Identifier: NCT02960243
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher Honey, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Essential Voice Tremor Deep Brain Stimulation Essential Tremor Laryngeal Diseases Action Tremor Tremor, Nerve Device: Deep Brain Stimulation Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Left, Right, or Bilateral Thalamic Deep Brain Stimulation for Voice Tremor: A Prospective, Randomized, Double-Blinded Trial
Study Start Date : August 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Sham Comparator: Bilateral Thalamic Vim OFF

Participants with bilateral thalamic DBS will be tested four times over 90 minutes. The four tests will include the following in a randomized, double-blinded order:

First test: both stimulators on for 15 minutes Second test: left stimulator off, right stimulator on for 15 minutes Third test: left stimulator on, right stimulator off for 15 minutes Fourth test: both stimulators off for 15 minutes

In between switching to each test, there will be a 5 minute washout period.

Device: Deep Brain Stimulation
  • 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 Name: DBS

Experimental: Left Thalamic Vim ON

Participants with bilateral thalamic DBS will be tested four times over 90 minutes. The four tests will include the following in a randomized, double-blinded order:

First test: both stimulators on for 15 minutes Second test: left stimulator off, right stimulator on for 15 minutes Third test: left stimulator on, right stimulator off for 15 minutes Fourth test: both stimulators off for 15 minutes

In between switching to each test, there will be a 5 minute washout period.

Device: Deep Brain Stimulation
  • 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 Name: DBS

Experimental: Right Thalamic Vim ON

Participants with bilateral thalamic DBS will be tested four times over 90 minutes. The four tests will include the following in a randomized, double-blinded order:

First test: both stimulators on for 15 minutes Second test: left stimulator off, right stimulator on for 15 minutes Third test: left stimulator on, right stimulator off for 15 minutes Fourth test: both stimulators off for 15 minutes

In between switching to each test, there will be a 5 minute washout period.

Device: Deep Brain Stimulation
  • 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 Name: DBS

Experimental: Bilateral Thalamic Vim ON

Participants with bilateral thalamic DBS will be tested four times over 90 minutes. The four tests will include the following in a randomized, double-blinded order:

First test: both stimulators on for 15 minutes Second test: left stimulator off, right stimulator on for 15 minutes Third test: left stimulator on, right stimulator off for 15 minutes Fourth test: both stimulators off for 15 minutes

In between switching to each test, there will be a 5 minute washout period.

Device: Deep Brain Stimulation
  • 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 Name: DBS




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960243


Contacts
Contact: Christopher R Honey, MD, DPhil 604 875 5894 chris.honey@telus.net
Contact: Olivia B Chorny olivia.chorny@gmail.com

Locations
Canada, British Columbia
The Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Christopher R Honey, MD, DPhil    604.875.5894    chris.honey@telus.net   
Contact: Olivia B Chorny       olivia.chorny@gmail.com   
Sponsors and Collaborators
University of British Columbia

Publications of Results:
Responsible Party: Christopher Honey, Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders, University of British Columbia
ClinicalTrials.gov Identifier: NCT02960243     History of Changes
Other Study ID Numbers: H16-01694
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016

Keywords provided by Christopher Honey, University of British Columbia:
Deep Brain Stimulation
Laryngeal Motor Cortex
Essential Voice Tremor
Essential Tremor

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