Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS-on | Experimental | Ventral intermediate Nucleus (VIM) Thalamic DBS on DBS system includes:
|
|
| DBS-off (sham-stimulation) | Sham Comparator | Ventral intermediate Nucleus (VIM) Thalamic DBS off DBS system includes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIM Thalamic Deep Brain Stimulation ON | Device |
| ||
| VIM Thalamic Deep Brain Stimulation OFF |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher R Honey, MD, DPhil | UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vancouver General Hospital | Vancouver | British Columbia | V5Z 4E3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18922334 | Background | 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. | |
| 18083751 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DBS-on First, Then DBS-off (Sham-stimulation) | Ventral intermediate Nucleus (VIM) Thalamic DBS on for the first 3 months, then Thalamic DBS off for the next 3 months DBS system includes:
VIM Thalamic DBS ON for first 3 months, then Thalamic DBS OFF for following 3 months |
| FG001 | DBS-off First (Sham-stimulation), Then DBS-on | Ventral intermediate Nucleus (VIM) Thalamic DBS off (Sham-stimulation) for the first 3 months, then Thalamic DBS on for the following 3 months DBS system includes:
VIM Thalamic Deep Brain Stimulation OFF for first 3 months, followed by VIM Thalamic Deep Brain Stimulation ON for the following 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Blinded: First Intervention (3 Months) |
| |||||||||||||
| Blinded: Second Intervention (3 Months) |
| |||||||||||||
| Unblinded: DBS on (6 Months) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One patient requested to have their DBS on after 2 weeks of being in the blinded-DBS OFF after the first crossover. | Posted | Median | Standard Deviation | units on a scale | After the first 6 months, the participants completed the USDRS twice (once per crossover). |
|
The study took place from January 1, 2017 - May 30, 2018. The study duration was approximately 1.5 years.
This cohort continues to be followed and any future adverse events will be reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded DBS-ON | When DBS was turned on, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Chisholm, Manager, Internal Awards | Vancouver Coastal Health Research Association | 6048754111 | 21696 | amanda.chisholm@vch.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2017 | Oct 26, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| 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) | 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 | 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). |
| 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. |
| 38251897 | Derived | 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. |
| 33862624 | 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. |
| 28304188 | 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. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patients who are currently receiving BTX injections for their voice disorder | Count of Participants | Participants |
|
| Patients who experience fluctuations in their symptom control as a result of their BTX therapy | Count of Participants | Participants |
|
| OG001 | Blinded-DBS OFF | All participants who at some point in the study were in the 3-month blinded DBS OFF intervention. |
|
|
|
| Primary | 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. | Posted | Median | Standard Deviation | units on a scale | After the first 6 months, the participants completed the V-RQoL twice (once per crossover). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | All participants completed the BDI-II once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | All participants completed the MoCA once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase). |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Blinded DBS-OFF | When DBS was turned off, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Open DBS-ON | When DBS was turned on, none of the patients had any adverse clinical events during the trial. There were no asymptomatic hemorrhages detected on the post-operative CT scans. At the conclusion of the trial (1-year post-operative), there had been no infections, erosions, or technical malfunctions. The cohort continues to be followed and future adverse event will be reported. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |