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

NCT02960243 | Completed

• 1 other identifier: H16-01694
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Voice Tremor Severity

  Measured every 3 minutes for 15 minutes

Study Arms (4)

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.

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.

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.

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.

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

* 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

Also known as: DBS

Bilateral Thalamic Vim OFF; Bilateral Thalamic Vim ON; Left Thalamic Vim ON; Right Thalamic Vim ON

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has been implanted with the DBS for ET
• Participant has significant voice tremor as determined by our laryngology/speech-language pathology team

You may not qualify if:

• Participant does not have history of aphasia or other speech/language deficits
• Participant does not have history of stroke or multiple sclerosis

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (3)

• 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.

  PMID: 19940187 RESULT

• 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.

  PMID: 21384292 RESULT

• 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.

  PMID: 11391740 RESULT

MeSH Terms

Conditions

Essential Tremor; Laryngeal Diseases; Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

Study Record Dates

• First Submitted: November 5, 2016
• First Posted: November 9, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)