Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres? - Clinical Trial for Essential Voice Tremor | NCT02960243

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Deep Brain Stimulation

About this trial

This is an interventional treatment trial for Essential Voice Tremor focused on measuring Deep Brain Stimulation, Laryngeal Motor Cortex, Essential Voice Tremor, Essential Tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Arm Label

Bilateral Thalamic Vim OFF

Left Thalamic Vim ON

Right Thalamic Vim ON

Bilateral Thalamic Vim ON

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02960243

First Posted

November 5, 2016

Last Updated

April 26, 2021

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02960243

Brief Title

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

Acronym

EVT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

December 2020 (Actual)

Study Completion Date

December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bilateral Thalamic Vim OFF

Arm Type

Sham Comparator

Arm Description

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.

Arm Title

Left Thalamic Vim ON

Arm Type

Experimental

Arm Description

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.

Arm Title

Right Thalamic Vim ON

Arm Type

Experimental

Arm Description

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.

Arm Title

Bilateral Thalamic Vim ON

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Deep Brain Stimulation

Other Intervention Name(s)

DBS

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Voice Tremor Severity

Description

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

Time Frame

Measured every 3 minutes for 15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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

Facility Information:

Facility Name

The Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19940187

Citation

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.

Results Reference

result

PubMed Identifier

21384292

Citation

Mandat 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 Reference

result

PubMed Identifier

11391740

Citation

Koller 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.

Results Reference

result

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

Essential Voice Tremor, Deep Brain Stimulation, Essential Tremor

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial