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Spasmodic DysphoniaNCT02558634

Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

A study testing VIM Thalamic Deep Brain Stimulation ON and VIM Thalamic Deep Brain Stimulation OFF in people with Spasmodic Dysphonia and Laryngeal Dystonia, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
VIM Thalamic Deep Brain Stimulation ON and VIM Thalamic Deep Brain Stimulation OFF
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteCanada
Study dates
Jan 2016to Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Vancouver General Hospital

    Vancouver, British Columbia, V5Z 4E3

Other trials in Canada

About this study

Official title: 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.

Being tested
VIM Thalamic Deep Brain Stimulation ON, VIM Thalamic Deep Brain Stimulation OFF
Medical subject headings
Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIM Thalamic Deep Brain Stimulation ONDevice

  • VIM Thalamic Deep Brain Stimulation OFFDevice

Study groups in NCT02558634
Study groupRoleWhat they receive
DBS-onExperimentalVentral intermediate Nucleus (VIM) Thalamic DBS on DBS system includes: * Implantable Pulse Generator (IPG) * DBS Lead * DBS Lead Extension Kit
Receives: Device: VIM Thalamic Deep Brain Stimulation ON
DBS-off (sham-stimulation)Sham comparatorVentral intermediate Nucleus (VIM) Thalamic DBS off DBS system includes: * Implantable Pulse Generator (IPG) * DBS Lead * DBS Lead Extension Kit
Receives: Device: VIM Thalamic Deep Brain Stimulation OFF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (3)

  1. Beck's Depression Inventory Scale

    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.

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

  2. Montreal Cognitive Assessment Scale (MoCA)

    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.

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

  3. Voice-Handicap Index

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionMay 2019
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02558634
Sponsor's protocol ID
H15-02535
Status last verified
May 2022
First submitted
22 Sep 2015
Last updated
14 Jun 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18922334

  • 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.

    PubMed 18083751

  • Hart MG, Polyhronopoulos N, Sandhu MK, Honey CR. Deep Brain Stimulation Improves Symptoms of Spasmodic Dysphonia Through Targeting of Thalamic Sensorimotor Connectivity. Neurosurgery. 2024 Jun 1;94(6):1291-1300. doi: 10.1227/neu.0000000000002836. Epub 2024 Jan 22.

    PubMed 38251897

  • 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.

    PubMed 33862624

  • 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.

    PubMed 28304188

Questions about this trial

What is this clinical trial studying?

A study testing VIM Thalamic Deep Brain Stimulation ON and VIM Thalamic Deep Brain Stimulation OFF in people with Spasmodic Dysphonia and Laryngeal Dystonia, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Spasmodic Dysphonia Rating Scale (USDRS) (time frame: After the first 6 months, the participants completed the USDRS twice (once per crossover).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02558634, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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