Clinical trial NCT02960243: Deep Brain Stimulation for Voice Tremor: Left, Right, or Both Hemispheres?
Official title: Left, Right, or Bilateral Thalamic Deep Brain Stimulation for Voice Tremor: A Prospective, Randomized, Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
timeFrame: At the end of each trial period, typically 15 minutes after change in stimulation settings
Secondary outcomes:
measure: Voice Tremor Severity
timeFrame: Measured every 3 minutes for 15 minutes
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Vancouver General Hospital
state: British Columbia
Study officials:
References:
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.
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.
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.