Essential Voice TremorEVTNCT02960243
Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres?
A study testing Deep Brain Stimulation in people with Essential Voice Tremor and Deep Brain Stimulation, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Voice Tremor, Deep Brain Stimulation, Essential Tremor
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has been implanted with the DBS for ET
- Participant has significant voice tremor as determined by our laryngology/speech-language pathology team
Who cannot join
- Participant does not have history of aphasia or other speech/language deficits
- Participant does not have history of stroke or multiple sclerosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Left, Right, or Bilateral Thalamic Deep Brain Stimulation for Voice Tremor: A Prospective, Randomized, Double-Blinded Trial
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.
Read the 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.
- Conditions
- Essential Voice Tremor, Deep Brain Stimulation, Essential Tremor, Laryngeal Diseases, Action Tremor, Tremor, Nerve
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Laryngeal Motor Cortex, Essential Voice Tremor, Essential Tremor
- Medical subject headings
- Essential Tremor, Laryngeal Diseases, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called DBS
- 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
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Thalamic Vim OFF | Sham comparator | 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. Receives: Device: Deep Brain Stimulation |
| Left Thalamic Vim ON | Experimental | 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. Receives: Device: Deep Brain Stimulation |
| Right Thalamic Vim ON | Experimental | 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. Receives: Device: Deep Brain Stimulation |
| Bilateral Thalamic Vim ON | Experimental | 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. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
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.
Measured: At the end of each trial period, typically 15 minutes after change in stimulation settings
Secondary outcomes (1)
Voice Tremor Severity
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
Measured: Measured every 3 minutes for 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Essential Voice TremorStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Honey, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960243
- Sponsor's protocol ID
- H16-01694
- Acronym
- EVT
- Status last verified
- Apr 2021
- First submitted
- 5 Nov 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Simonyan K, Ostuni J, Ludlow CL, Horwitz B. Functional but not structural networks of the human laryngeal motor cortex show left hemispheric lateralization during syllable but not breathing production. J Neurosci. 2009 Nov 25;29(47):14912-23. doi: 10.1523/JNEUROSCI.4897-09.2009.
PubMed 19940187Mandat T, Koziara H, Rola R, Bonicki W, Nauman P. Thalamic deep brain stimulation in the treatment of essential tremor. Neurol Neurochir Pol. 2011 Jan-Feb;45(1):37-41. doi: 10.1016/s0028-3843(14)60058-x.
PubMed 21384292Koller WC, Lyons KE, Wilkinson SB, Troster AI, Pahwa R. Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. Mov Disord. 2001 May;16(3):464-8. doi: 10.1002/mds.1089.
PubMed 11391740
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left, Right, or Bilateral Thalamic Deep Brain Stimulation for Voice Tremor: A Prospective, Randomized, Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT02960243
- Acronym / sponsor ID
- EVT / H16-01694
- Conditions
- Essential Voice Tremor, Deep Brain Stimulation, Essential Tremor, Laryngeal Diseases, Action Tremor, Tremor, Nerve
- Keywords
- Deep Brain Stimulation, Laryngeal Motor Cortex, Essential Voice Tremor, Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bilateral Thalamic Vim OFF | Sham comparator | Device: Deep Brain StimulationParticipants 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. |
| Left Thalamic Vim ON | Experimental | Device: Deep Brain StimulationParticipants 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. |
| Right Thalamic Vim ON | Experimental | Device: Deep Brain StimulationParticipants 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. |
| Bilateral Thalamic Vim ON | Experimental | Device: Deep Brain StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant has been implanted with the DBS for ET
- Participant has significant voice tremor as determined by our laryngology/speech-language pathology team
Key exclusion criteria (2 listed)
- Participant does not have history of aphasia or other speech/language deficits
- Participant does not have history of stroke or multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: DBS* 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 | Device | Bilateral Thalamic Vim OFF, Bilateral Thalamic Vim ON, Left Thalamic Vim ON, Right Thalamic Vim ON |
Primary outcome
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.
1 secondary outcome
Voice Tremor Severity
Time frame: Measured every 3 minutes for 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Results publication: PubMed 19940187Simonyan K, Ostuni J, Ludlow CL, Horwitz B. Functional but not structural networks of the human laryngeal motor cortex show left hemispheric lateralization during syllable but not breathing production. J Neurosci. 2009 Nov 25;29(47):14912-23. doi: 10.1523/JNEUROSCI.4897-09.2009.
- Results publication: PubMed 21384292Mandat T, Koziara H, Rola R, Bonicki W, Nauman P. Thalamic deep brain stimulation in the treatment of essential tremor. Neurol Neurochir Pol. 2011 Jan-Feb;45(1):37-41. doi: 10.1016/s0028-3843(14)60058-x.
- Results publication: PubMed 11391740Koller WC, Lyons KE, Wilkinson SB, Troster AI, Pahwa R. Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. Mov Disord. 2001 May;16(3):464-8. doi: 10.1002/mds.1089.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Essential Voice Tremor and Deep Brain Stimulation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960243, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.