Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

NCT02558634 | Completed Results DMC

• 1 other identifier: H15-02535
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Laryngeal Dystonia (LD), also commonly referred to as spasmodic dysphonia, is a neurological voice disorder characterized by involuntary dystonic contractions of the laryngeal muscles. Current treatments such as botox and voice therapy only provide temporary relief and thus, the investigators are exploring new strategies to provide long-term, sustained improvement. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves the implantation of electrodes to deliver electrical stimuli to specific brain regions. It is the standard surgical treatment for many other movement disorders such as Parkinson's disease, essential tremor, and primary dystonia. This trial has been designed to test the hypothesis that DBS can improve the vocal dysfunction of LD.

Conditions

Spasmodic Dysphonia; Laryngeal Dystonia; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Unified Spasmodic Dysphonia Rating Scale (USDRS)

  Assessments of spasmodic dysphonia using a standardized spasmodic dysphonia rating scale were done pre-operatively, blinded DBS ON, blinded DBS OFF, and open DBS ON. Voice recording taken of each patient reading standardized sentences were blinded and evaluated by two speech language pathologists. The scale ranges from 0-7, with lower scores being better and higher scores being worse.

  After the first 6 months, the participants completed the USDRS twice (once per crossover).

• Voice-Related Quality of Life

  Double-blinded assessments of voice-related quality of life with DBS ON/OFF were conducted using the V-RQoL for Spasmodic Dysphonia. The V-RQoL is a questionnaire that measures a patient's voice related quality of life. The scale ranges from 0-50, with higher scores representing a lower quality of life with respect to voice.

  After the first 6 months, the participants completed the V-RQoL twice (once per crossover).

Secondary Outcomes (3)

• Beck's Depression Inventory Scale

  All participants completed the BDI-II once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).

• Montreal Cognitive Assessment Scale (MoCA)

  All participants completed the MoCA once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).

• Voice-Handicap Index

  All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).

Study Arms (2)

DBS-on

EXPERIMENTAL

Ventral intermediate Nucleus (VIM) Thalamic DBS on DBS system includes: * Implantable Pulse Generator (IPG) * DBS Lead * DBS Lead Extension Kit

Device: VIM Thalamic Deep Brain Stimulation ON

DBS-off (sham-stimulation)

SHAM COMPARATOR

Ventral intermediate Nucleus (VIM) Thalamic DBS off DBS system includes: * Implantable Pulse Generator (IPG) * DBS Lead * DBS Lead Extension Kit

Device: VIM Thalamic Deep Brain Stimulation OFF

Interventions

VIM Thalamic Deep Brain Stimulation ON DEVICE

DBS-on

VIM Thalamic Deep Brain Stimulation OFF DEVICE

DBS-off (sham-stimulation)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed isolated laryngeal dystonia (adductor spasmodic dysphonia)
• Able to give informed consent
• Patients who fall into the age range of 18-75 years old
• Patients with inadequate medical and BTX management of spasmodic dysphonia

You may not qualify if:

• Dystonia present in other body parts (i.e- eyes, neck, limbs) in addition to larynx
• History of laryngeal denervation surgery for spasmodic dysphonia
• History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
• History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
• Incompetent adults or those unable to communicate.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

Location

Related Publications (5)

• Ludlow CL, Adler CH, Berke GS, Bielamowicz SA, Blitzer A, Bressman SB, Hallett M, Jinnah HA, Juergens U, Martin SB, Perlmutter JS, Sapienza C, Singleton A, Tanner CM, Woodson GE. Research priorities in spasmodic dysphonia. Otolaryngol Head Neck Surg. 2008 Oct;139(4):495-505. doi: 10.1016/j.otohns.2008.05.624.

  PMID: 18922334 BACKGROUND

• Simonyan K, Tovar-Moll F, Ostuni J, Hallett M, Kalasinsky VF, Lewin-Smith MR, Rushing EJ, Vortmeyer AO, Ludlow CL. Focal white matter changes in spasmodic dysphonia: a combined diffusion tensor imaging and neuropathological study. Brain. 2008 Feb;131(Pt 2):447-59. doi: 10.1093/brain/awm303. Epub 2007 Dec 14.

  PMID: 18083751 BACKGROUND

• Hart MG, Polyhronopoulos N, Sandhu MK, Honey CR. Deep Brain Stimulation Improves Symptoms of Spasmodic Dysphonia Through Targeting of Thalamic Sensorimotor Connectivity. Neurosurgery. 2024 Jan 22;94(6):1291-300. doi: 10.1227/neu.0000000000002836. Online ahead of print.

  PMID: 38251897 DERIVED

• Honey CR, Kruger MT, Almeida T, Rammage LA, Tamber MS, Morrison MD, Poologaindran A, Hu A. Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Phase I Prospective Randomized Double-Blind Crossover Trial. Neurosurgery. 2021 Jun 15;89(1):45-52. doi: 10.1093/neuros/nyab095.

  PMID: 33862624 DERIVED

• Poologaindran A, Ivanishvili Z, Morrison MD, Rammage LA, Sandhu MK, Polyhronopoulos NE, Honey CR. The effect of unilateral thalamic deep brain stimulation on the vocal dysfunction in a patient with spasmodic dysphonia: interrogating cerebellar and pallidal neural circuits. J Neurosurg. 2018 Feb;128(2):575-582. doi: 10.3171/2016.10.JNS161025. Epub 2017 Mar 17.

  PMID: 28304188 DERIVED

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amanda Chisholm, Manager, Internal Awards
• Organization: Vancouver Coastal Health Research Association

amanda.chisholm@vch.ca

6048754111

Study Officials

• Christopher R Honey, MD, DPhil

  UBC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• 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: September 22, 2015
• First Posted: September 24, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: June 14, 2022
• Results First Posted: March 29, 2022

Record last verified: 2022-05

Locations

CA (1)