Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

VIM Thalamic Deep Brain Stimulation ON

VIM Thalamic Deep Brain Stimulation OFF

About this trial

This is an interventional treatment trial for Spasmodic Dysphonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

DBS-on

DBS-off (sham-stimulation)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02558634

First Posted

September 22, 2015

Last Updated

May 20, 2022

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02558634

Brief Title

Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spasmodic Dysphonia, Laryngeal Dystonia, Deep Brain Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DBS-on

Arm Type

Experimental

Arm Description

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

Arm Title

DBS-off (sham-stimulation)

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

VIM Thalamic Deep Brain Stimulation ON

Intervention Type

Device

Intervention Name(s)

VIM Thalamic Deep Brain Stimulation OFF

Primary Outcome Measure Information:

Title

Unified Spasmodic Dysphonia Rating Scale (USDRS)

Description

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.

Time Frame

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

Title

Voice-Related Quality of Life

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Beck's Depression Inventory Scale

Description

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.

Time Frame

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

Title

Montreal Cognitive Assessment Scale (MoCA)

Description

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.

Time Frame

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

Title

Voice-Handicap Index

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher R Honey, MD, DPhil

Organizational Affiliation

UBC

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E3

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

18922334

Citation

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.

Results Reference

background

PubMed Identifier

18083751

Citation

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.

Results Reference

background

PubMed Identifier

33862624

Citation

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.

Results Reference

derived

PubMed Identifier

28304188

Citation

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.

Results Reference

derived

Spasmodic Dysphonia, Laryngeal Dystonia, Deep Brain Stimulation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial