Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

May 20, 2022 updated by: Christopher Honey, University of British Columbia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E3
        • The Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DBS-on

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
SHAM_COMPARATOR: DBS-off (sham-stimulation)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After the first 6 months, the participants completed the USDRS twice (once per crossover).
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.
After the first 6 months, the participants completed the V-RQoL twice (once per crossover).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
All participants completed the MoCA once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).
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.
All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

May 1, 2019

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (ESTIMATE)

September 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15-02535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Brain Stimulation

Clinical Trials on VIM Thalamic Deep Brain Stimulation ON

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe