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

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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Publications of Results:

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.

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.

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.

• 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
• 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