Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres? (EVT)
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ClinicalTrials.gov Identifier: NCT02960243 |
Recruitment Status :
Completed
First Posted : November 9, 2016
Last Update Posted : April 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Voice Tremor Deep Brain Stimulation Essential Tremor Laryngeal Diseases Action Tremor Tremor, Nerve | Device: Deep Brain Stimulation | Not Applicable |
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) |
Actual Enrollment : | 6 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 |
Actual Study Start Date : | August 2016 |
Actual Primary Completion Date : | December 2020 |
Actual Study Completion Date : | December 2020 |

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
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
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
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
Other Name: DBS |
- 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.
- 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

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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 |
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

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
Canada, British Columbia | |
The Vancouver General Hospital | |
Vancouver, British Columbia, Canada, V5Z 1M9 |
Responsible Party: | Christopher Honey, Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT02960243 |
Other Study ID Numbers: |
H16-01694 |
First Posted: | November 9, 2016 Key Record Dates |
Last Update Posted: | April 28, 2021 |
Last Verified: | April 2021 |
Deep Brain Stimulation Laryngeal Motor Cortex Essential Voice Tremor Essential Tremor |
Laryngeal Diseases Tremor Essential Tremor Dyskinesias Neurologic Manifestations |
Nervous System Diseases Movement Disorders Central Nervous System Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |