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

Essential Tremor Clinical Trial

— EVT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960243
• Other study ID #: H16-01694
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Action Tremor
• Deep Brain Stimulation
• Essential Tremor
• Essential Voice Tremor
• Laryngeal Diseases
• Tremor
• Tremor, Nerve

Intervention

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

Locations

Country	Name	City	State
Canada	The Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of each trial period, typically 15 minutes after change in stimulation settings
Secondary	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 every 3 minutes for 15 minutes