An interventional study of VIM Thalamic Deep Brain Stimulation ON and VIM Thalamic Deep Brain Stimulation OFF in Spasmodic Dysphonia, Laryngeal Dystonia and Deep Brain Stimulation, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's enrollment of 6 is below the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 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.
Time frame: After the first 6 months, the participants completed the V-RQoL twice (once per crossover).
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.
Time frame: 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.
Time frame: 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.
Time frame: All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).
| Milestone | DBS-on First, Then DBS-off (Sham-stimulation) | DBS-off First (Sham-stimulation), Then DBS-on |
|---|---|---|
| Started | 4 | 2 |
| Completed | 4 | 2 |
| Not completed | 0 | 0 |
| Milestone | DBS-on First, Then DBS-off (Sham-stimulation) | DBS-off First (Sham-stimulation), Then DBS-on |
|---|---|---|
| Started | 4 | 2 |
| Completed | 3 | 2 |
| Not completed | 1 | 0 |
| Milestone | DBS-on First, Then DBS-off (Sham-stimulation) | DBS-off First (Sham-stimulation), Then DBS-on |
|---|---|---|
| Started | 4 | 2 |
| Completed | 4 | 2 |
| Not completed | 0 | 0 |
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.
| units on a scale | Blinded-DBS ON | Blinded-DBS OFF |
|---|---|---|
| Unified Spasmodic Dysphonia Rating Scale (USDRS) | 2.5 ± 1.4 | 3.75 ± 1.0 |
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.
| units on a scale | Blinded-DBS ON | Blinded-DBS OFF |
|---|---|---|
| Voice-Related Quality of Life | 74.7 ± 18.3 | 19 ± 18.2 |
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.
| units on a scale | Open-DBS ON |
|---|---|
| Pre-Operative BDI-II | 13.33 ± 7.20 |
| One Year Follow-Up BDI-II | 6.50 ± 6.47 |
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.
| units on a scale | Open-DBS ON |
|---|---|
| Pre-Operative MoCA | 24.17 ± 3.08 |
| One Year Follow-Up MoCA | 26.67 ± 3.09 |
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.
| units on a scale | Open-DBS ON |
|---|---|
| Pre-Operative VHI | 84.83 ± 15.52 |
| 1 Year Post-Operative VHI | 38.17 ± 13.15 |
Collected over The study took place from January 1, 2017 - May 30, 2018. The study duration was approximately 1.5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blinded DBS-ON | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Blinded DBS-OFF | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Open DBS-ON | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 65.17 ± 8.27 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 5 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| Canada | 6 |
| Patients who are currently receiving BTX injections for their voice disorder(Participants) | All Study Participants |
|---|---|
| Count of participants | 6 |
| Patients who experience fluctuations in their symptom control as a result of their BTX therapy(Participants) | All Study Participants |
|---|---|
| Count of participants | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2016 to primary completion in May 2019, 40 months.
Results were first posted in Mar 2022, 2 years 10 months after primary completion.
Of 44 non-industry interventional studies with no phase under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 40 months is above that.
Counting every sponsor, half of 44 studies reached it within 26 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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