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NCT Number: NCT02558634

Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

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.

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Key information

Conditions

Spasmodic Dysphonia Deep Brain Stimulation Dysphonia Laryngeal Diseases Laryngeal Dystonia Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

VIM Thalamic Deep Brain Stimulation ON

Device

VIM Thalamic Deep Brain Stimulation OFF

Device

Primary outcomes

  1. Unified Spasmodic Dysphonia Rating Scale (USDRS)

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

    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.

  2. Voice-Related Quality of Life

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

    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.

Secondary outcomes

  1. Beck's Depression Inventory Scale

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

    Beck's Depression Inventory Scale (BDI-II) was used in this study to evaluate the mood of the patients both pre-operatively and at the end of the one-year study.

    All 6 patients completed the BDI-II, which is a scale that identifies symptoms and attitudes associated with depression, and evaluates the presence and severity of depression. The BDI-II ranges from 0-63. Scores ranging from 0-10 are considered to be absent or minimal depression, 10-18 indicate mild to moderate depression, 19-29 indicate moderate depression, and 30-63 indicate severe depression.

  2. Montreal Cognitive Assessment Scale (MoCA)

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

    The MoCA was used to analyze the cognitive ability of the patients. It was first evaluated pre-operatively and again evaluated at the end of the one-year study. The MoCA scale ranges from 0-30 with higher scores indicating less cognitive impairment. Scores ranging from 18-25 indicate mild cognitive impairment, 10-17 indicate moderate cognitive impairment, and scores less than 10 indicate severe cognitive impairment.

  3. Voice-Handicap Index

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

    The Voice-Handicap Index (VHI) is a questionnaire that measures the patients' perceived degree of handicap related to their voice. The VHI ranges from a scale of 0-100, with higher scores reflecting higher perceived degree of voice handicap and lower scores reflecting lower perceived degree of voice handicap.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Thalamic Deep Brain Stimulation for Spasmodic Dysphonia: A Prospective, Randomized, Double-Blinded, Sham-Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 24, 2015
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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