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

NCT ID: NCT02960243

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Deep Brain Stimulation

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

DBS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Christopher Honey

Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 19940187 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21384292 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11391740 (View on PubMed)

Other Identifiers

H16-01694

Identifier Type: -

Identifier Source: org_study_id